REMstar System One 60 Series
REMstar Pro with C-Flex+ System One 60 series CPAP System with Heated Tube Humidifier and Bluetooth (American Home Patient unit)
18manufacturers in China registered for this device type
163catalogue numbers in this listing
67510(k) clearances naming this product code
35recalls on this code
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (2), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Suzhou Avon Textile Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Hunan Beyond Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 3 |
| Shanghai Baron Technologies Co Ltd | Shanghai | Shanghai | Contract manufacturer | 3 |
| BMC(Dongguan) Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Zhejiang Baron Technologies Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Resvent Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Showing 12 of 18. All 18 manufacturers in China registered for Ventilator, Non-Continuous (Respirator)
Record
| Listed by | Respironics Inc., United States |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K113068 |
| Record published | 2016-08-20 |
| Record revised | 2021-03-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment temperature -20 to 60 °C; Storage environment temperature -4 to 140 °F |
| Distribution end date | 2024-08-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REMstar Auto A-Flex with Humidifier, 60 Series, CA | In distribution | |
| REMstar Auto, US | In distribution | |
| REMstar Plus C-Flex, 60 Series, INTL | In distribution | |
| REMstar Auto A-Flex, System One 60 Series, NO | In distribution | |
| REMstar Auto A-Flex, 60 Series, CA | In distribution | |
| REMstar Plus C Flex, System One 60 Series, ES | In distribution | |
| REMstar Pro C-Flex+w/Hum, SysOne 60 Series, ZA | In distribution | |
| REMstar Pro C-Flex+, w/Humid, System One 60 Srs, PT | In distribution | |
| REMstar Auto A-Flex, with Humidifier, 60 Series, AHP | In distribution | |
| REMstar Plus C Flex, w/Humid, Sys One 60 Series, SE | In distribution | |
| REMstar Auto A-Flex, System One 60 Series, PT | In distribution | |
| REMstar Auto w/Htd Humid, St Tube, w/Btooth, 60 Srs, CA | In distribution | |
| REMstar Auto A-Flex, with Humidifier, 60 Series, INTL | In distribution | |
| REMstar Auto A-Flex, w/Humid System One 60 Series US | In distribution | |
| REMstar Pro C-Flex+, System One 60 Series, PT | In distribution | |
| REMstar Pro C-Flex+, 60 Series, INTL | In distribution | |
| REMstar Pro C-Flex+, w/H Tube Humid, w/Btooth, 60 Srs, AHP | In distribution | |
| REMstar Auto A Flex, Sys One, 60 Srs, ND | In distribution | |
| REMstar Auto A-Flex w/HT Humid, BTOOTH Sys One 60 Srs, US | In distribution | |
| REMstar Pro C-Flex+ w/ Humid, BTOOTH Sys One 60 Srs, US | In distribution | |
| REMstar Pro C-Flex+, System One 60 Series, SE | In distribution | |
| REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, AU | In distribution | |
| REMstar Pro C-Flex+, with Humidifier, 60 Series, AU | In distribution | |
| REMstar Plus, 60 Series, CA | In distribution | |
| REMstar Auto A-Flex, System One 60 Series, ES | In distribution | |
| REMstar Pro C-Flex+, 60 Series, AU | In distribution | |
| REMstar Pro C-Flex+, w/H Tube Humid, w/Btooth, 60 Srs, CA | In distribution | |
| REMstar Pro, INTL | In distribution | |
| REMstar Plus, w/H Tube Humid, 60 Series, CA | In distribution | |
| REMstar Pro C-Flex+, 60 Series, CA | In distribution | |
| REMstar Pro C-Flex+, with BlueTooth, 60 Series, CA | In distribution | |
| REMstar Auto A-Flex, System One 60 Series, GB | In distribution | |
| REMstar Auto A-Flex, wHumid, Sys One 60 Srs, SE | In distribution | |
| REMstar Plus C-Flex, System One 60 Series, GB | In distribution | |
| REMstar Auto A-Flex, w/H Tube Humid, 60 Series, AHP | In distribution | |
| REMstar Pro, CA | In distribution | |
| REMstar Auto P-Flex, w/Humid, Sys One 60 Srs, FR | In distribution | |
| REMstar Auto A-Flex, w/H Tube Humid, 60 Series, CA | In distribution | |
| REMstar AutoA-Flex with Humidifier, System One 60 Series, ES | In distribution | |
| REMStar Auto w/BlueTooth, US | In distribution | |
| REMstar Auto A-Flex, System One 60 Series, SE | In distribution | |
| REMstar Auto A-Flex, 60 Series, AU | In distribution | |
| REMStar Pro, w/BlueTooth, US | In distribution | |
| REMstar Plus C Flex, w/Humid, System One 60 Series, ES | In distribution | |
| REMstar Pro C-Flex+, w/HT Humid System One 60 Series US | In distribution | |
| REMstar Plus C-Flex, System One 60 Series, Latin America | In distribution | |
| REMstar Plus C Flex, System One 60 Series, Italy | In distribution | |
| REMstar Pro, US | In distribution | |
| REMstar Auto A-Flex, w/H Tube Humid, 60 Series, INTL | In distribution | |
| REMstar Pro C-Flex+, System One 60 Series, FI | In distribution | |
| REMstar Plus C Flex, w/Humid, System One 60 Series, PT | In distribution | |
| REMstar Pro C-Flex+, System One 60 Series, GB | In distribution | |
| REMstar Plus, w/Humid System One 60 Series US | In distribution | |
| REMstar Auto A-Flex, 60 Series, AHP | In distribution | |
| REMstar Auto A-Flex, with Bluetooth, 60 Series, AHP | In distribution | |
| REMstar Pro C-Flex+, w/Humid, System One 60 Series, ES | In distribution | |
| REMstar Pro C-Flex+, with Humidifier, 60 Series, AHP | In distribution | |
| REMstar Auto A-Flex, System One 60 Series, FI | In distribution | |
| REMstar Plus CFlex, Sys One, 60 Series, ND | In distribution | |
| REMstar Plus, w/HT Humid System One 60 Series US | In distribution | |
| REMstar Pro C-Flex+, w/Humid System One 60 Series US | In distribution | |
| REMstar Auto A-Flex, w/Humid, System One 60 Srs, GB | In distribution | |
| REMstar Pro C-Flex+, w/Humid, System One 60 Srs, SE | In distribution | |
| REMstar Plus CFlex, w/Hum Sys One 60 Srs, ND | In distribution | |
| REMstar Plus CFlex, System One 60 Series, PT | In distribution | |
| REMstar Plus, CA | In distribution | |
| REMstar Pro C-Flex+, w/Humid, System One 60 Srs,GB | In distribution | |
| REMstar Pro w/BlueTooth, CA | In distribution | |
| REMstar Pro C-Flex+, BlueTooth Sys One 60 Series, US | In distribution | |
| REMstar Auto A-Flex, BTOOTH System One 60 Series, US | In distribution | |
| REMstar Pro C-Flex+, w/H T Hum, St Tube, BTooth, 60 Srs, CA | In distribution | |
| REMstar Auto A-Flex, w/H Tube Humid, 60 Series, AU | In distribution | |
| REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, AHP | In distribution | |
| REMstar Pro C Flex+, System One 60 Series, ND | In distribution | |
| REMstar Plus CFlex, System One 60 Series, SE | In distribution | |
| REMstar Auto, INTL | In distribution | |
| REMstar Pro C-Flex+, with Bluetooth, 60 Series, AHP | In distribution | |
| REMstar Pro C-Flex+, w/H Tube Humid, Sys One 60 Series, FR | In distribution | |
| REMstar Auto P-Flex, w/H Tube Humid, Sys One 60 Series, FR | In distribution | |
| REMstar Plus C-Flex, w/H Tube Humid, 60 Series, INTL | In distribution | |
| REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, CA | In distribution | |
| REMstar Auto A-Flex, w/H Tube Humid, St Tube, 60 Series, CA | In distribution | |
| REMstar Pro C-Flex+, w/ Humid, w/Bluetooth, 60 Series, AHP | In distribution | |
| REMstar Pro C-Flex+, w/Humid, with BTooth, 60 Series, CA | In distribution | |
| REMstar Auto P-Flex, FR | In distribution | |
| REMstar Auto w/HTD Humid, BlueTooth, 60 Series, CA | In distribution | |
| REMstar Pro C Flex+, w/Humid, System One 60 Srs, ND | In distribution | |
| REMstar Auto A-Flex w/Hum, System One 60 Series, ZA | In distribution | |
| REMstar Auto A-Flex, with BlueTooth, 60 Series, CA | In distribution | |
| REMstar AutoA-Flex with Humidifier, System One 60 Series, FI | In distribution | |
| REMstar Auto A-Flex w/Humidifier, Sys One 60 Srs, NO | In distribution | |
| REMstar Pro C-Flex+, w/Humid, Sys One 60 Series, FR | In distribution | |
| REMStar Auto, with BlueTooth, CA | In distribution | |
| REMstar Auto A-Flex, 60 Series, INTL | In distribution | |
| REMstar Pro C-Flex+, 60 Series, AHP | In distribution | |
| System One Heated Humidifier US | In distribution | |
| REMstar Auto, CA | In distribution | |
| REMstar Pro C-Flex+, w/H Tube Humid, w/St Tube, 60 Srs, CA | In distribution | |
| REMstar Plus C Flex, w/Humid, System One 60 Series, FI | In distribution | |
| REMstar Auto A Flex w/Hum, Sys One 60 Srs, ND | In distribution | |
| REMstar Pro C-Flex+, w/Humid, System One 60 Series, FI | In distribution | |
| REMstar Plus, w/H Tube Humid, Standard Tube, 60 Series, CA | In distribution | |
| REMstar Auto A-Flex w/ Humid, BTOOTH Sys One 60 Srs, US | In distribution | |
| REMstar Plus C Flex, w/Humid, System One 60 Series, IT | In distribution | |
| REMstar Pro C-Flex+ w/HT Humid, BTOOTH Sys One 60 Srs, US | In distribution | |
| REMstar Plus C-Flex, w/Humid, Sys One 60 Series, GB | In distribution | |
| REMstar Plus, 60 Series, AHP | In distribution | |
| REMstar Auto A-Flex, w/Humid, Sys One 60 Series, PT | In distribution | |
| REMstar Pro C-Flex+ System One, 60 Series, FR | In distribution | |
| REMstarAuto A-Flex w/Humid, w/Bluetooth,60 Srs, AHP | In distribution | |
| REMstar Auto C-Flex+ w/Humid, BlueTooth, 60 Srs, CA | In distribution | |
| REMstar Pro C-Flex+, BR | Withdrawn | |
| REMstar Pro C-Flex+, w/Humid, System One 60Series, JP | Withdrawn | |
| REMstar Auto A-Flex w/ Humid, System One 60 SRs, CN | Withdrawn | |
| REMstar Auto A-Flex, w/HT Humid System One 60 Srs CN | Withdrawn | |
| REMstar Plus, with Humidifier, 60 Series, CA | Withdrawn | |
| REMstar Auto, CN | Withdrawn | |
| REMstar Plus, CN | Withdrawn | |
| REMstar Pro C-Flex+, System One 60 Series, DE | Withdrawn | |
| REMstar Auto A-Flex, w/Humid System One 60 Series LA | Withdrawn | |
| REMstar Auto A-Flex, BR | Withdrawn | |
| REMstar Auto A-Flex System One 60 Series LA | Withdrawn | |
| REMstar Pro C-Flex+ System One 60 Series LA | Withdrawn | |
| REMstar Auto A-Flex w/HT Humid System One 60 Series, US | Withdrawn | |
| REMstar Pro C-Flex+ System One 60 Series US | Withdrawn | |
| REMstar Pro, JP | Withdrawn | |
| REMstar Pro C-Flex, System One 60 Series, France | Withdrawn | |
| REMstar Plus C-Flex, w/HT Humid System One 60 Series CN | Withdrawn | |
| REMstar Pro C-Flex+, w/HT Humid System One 60Series, JP | Withdrawn | |
| REMstar Pro, CN | Withdrawn | |
| REMstar Plus C-Flex, with Humidifier, 60 Series, INTL | Withdrawn | |
| REMstar Auto P-Flex, System One 60 Series, France | Withdrawn | |
| REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, INTL | Withdrawn | |
| REMstar Auto A-Flex, System One 60 Series, Germany | Withdrawn | |
| REMstar Pro C-Flex+, BR | Withdrawn | |
| REMstar Pro C-Flex+ w/ Humid, System One 60 Series, CN | Withdrawn | |
| REMstar Auto A-Flex w/Humid System One 60Series JP | Withdrawn | |
| REMstar Auto A-Flex, System One, 60 Series CN | Withdrawn | |
| REMstar Pro C-Flex, System One 60 Series, FR | Withdrawn | |
| REMstar Plus C-Flex, w/Humid, Sys One 60 Series, LA | Withdrawn | |
| REMstar Auto JP | Withdrawn | |
| REMstar Auto A-Flex, w/HT Humid System One 60 Series LA | Withdrawn | |
| REMstar Plus C-Flex, System One, 60 Series CN | Withdrawn | |
| REMstar Pro C-Flex+, w/HT Humid System One 60 Series LA | Withdrawn | |
| REMstar Auto A-Flex, System One 60 Series, FR | Withdrawn | |
| REMstar Auto, BR | Withdrawn | |
| REMstar Pro C-Flex+, System One 60Series, JP | Withdrawn | |
| REMstar Auto A-Flex, System One, 60 Series, DE | Withdrawn | |
| REMstar Plus, w/H Tube Humid, 60 Series, AHP | Withdrawn | |
| REMstar Pro C-Flex+, System One 60 Series, Germany | Withdrawn | |
| REMstar Plus, BR | Withdrawn | |
| REMstar Plus System One 60 Series US | Withdrawn | |
| REMstar Auto A-Flex W/SD Card JP | Withdrawn | |
| REMstar Pro C-Flex+, with Humidifier, 60 Series, INTL | Withdrawn | |
| REMstar Pro C-Flex+, w/Humid System One 60 Series LA | Withdrawn | |
| REMstar Pro C-Flex+, System One 60 Series CN | Withdrawn | |
| REMstar Auto A-Flex System One 60 Series FR | Withdrawn | |
| REMstar Plus, BR | Withdrawn | |
| REMstar Auto A-Flex System One 60 Series US | Withdrawn | |
| REMstar Auto A-Flex w/HT Humid System One 60 Series JP | Withdrawn | |
| REMstar Plus C-Flex, w/H Tube Humid, Sys One 60 Series, LA | Withdrawn | |
| REMstar Plus C-Flex w/ Humid, System One 60 Series, CN | Withdrawn | |
| REMstar Auto A-Flex, with Humidifier, 60 Series, AU | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DreamStation | Respironics Inc. | 386 |
| DreamWear | Respironics Inc. | 183 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 152 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 136 |
| Ventilator, Non-Continuous (Respirator) | Hans Rudolph, Inc. | 115 |
| BiPAP System One 60 Series | Respironics Inc. | 105 |
| Ventilator, Non-Continuous (Respirator) | Salter Labs | 85 |
| BiTrac Select | Pulmodyne Inc. | 79 |
| Yuwell Sleep Apnea Breathing Therapy Mask | Suzhou Yuyue Medical Technology Co., Ltd. | 76 |
| AF541 | Respironics Inc. | 71 |
| CPAP Masks | Sunset Healthcare Solutions, Inc. | 69 |
| Hudson RCI | Teleflex Medical LLC | 69 |
Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231313 | 2023-07-28 |
| K210844 | 2021-08-24 |
| K210386 | 2021-07-12 |
| K201439 | 2020-09-25 |
| K200480 | 2020-07-10 |
| K183226 | 2019-10-18 |
| K181053 | 2019-01-04 |
| K151120 | 2016-04-15 |
| K152356 | 2016-01-08 |
| K150639 | 2015-09-18 |
| K140980 | 2015-02-10 |
| K142554 | 2015-01-09 |
| K140268 | 2014-10-20 |
| K132168 | 2013-11-20 |
| K131982 | 2013-10-18 |
| K130077 | 2013-05-21 |
| K122847 | 2013-03-06 |
| K122769 | 2012-10-09 |
| K121631 | 2012-10-05 |
| K120562 | 2012-07-17 |
| K120145 | 2012-03-30 |
| K113068 | 2011-12-16 |
| K110405 | 2011-06-06 |
| K103395 | 2011-03-24 |
| K110008 | 2011-02-17 |
| K102502 | 2010-12-22 |
| K091112 | 2009-05-15 |
| K082558 | 2009-03-25 |
| K072996 | 2007-12-27 |
| K061034 | 2006-06-23 |
| K053352 | 2006-02-15 |
| K052110 | 2005-10-20 |
| K050759 | 2005-06-15 |
| K043607 | 2005-01-28 |
| K041010 | 2004-05-05 |
| K032834 | 2004-03-04 |
| K033759 | 2004-02-19 |
| K031460 | 2003-06-24 |
| K021861 | 2002-06-19 |
| K012554 | 2002-01-29 |
| K011714 | 2001-06-28 |
| K010263 | 2001-03-29 |
| K002465 | 2000-09-08 |
| K000705 | 2000-09-08 |
| K000994 | 2000-06-22 |
| K992969 | 1999-11-10 |
| K993433 | 1999-10-27 |
| K993307 | 1999-10-27 |
| K992336 | 1999-08-13 |
| K991648 | 1999-05-28 |
| K963761 | 1997-04-18 |
| K964363 | 1997-01-30 |
| K962203 | 1996-12-05 |
| K963250 | 1996-11-14 |
| K953930 | 1996-09-30 |
| K961915 | 1996-08-15 |
| K961626 | 1996-07-18 |
| K954572 | 1996-06-26 |
| K945938 | 1996-01-31 |
| K954207 | 1996-01-31 |
| K953341 | 1996-01-30 |
| K936047 | 1995-03-29 |
| K925587 | 1993-09-14 |
| K925920 | 1993-07-21 |
| K920699 | 1992-12-07 |
| K911856 | 1991-08-09 |
| K905540 | 1991-01-30 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Respironics Inc. | 510(k) number | 2021-06-14 | Class I | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. | 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total |
Recalls
9 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-06-30 | Class I | Process control | Devices may possess a programming error resulting in an incorrect device configuration. | 28 units | |
| 2025-06-30 | Class I | Process control | Devices may possess a programming error resulting in an incorrect device configuration. | 57 units | |
| 2025-06-30 | Class I | Process control | Devices may possess a programming error resulting in an incorrect device configuration. | 8 units | |
| 2023-02-10 | Class I | Software design (manufacturing process) | A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription sett | 1233 devices | |
| 2022-09-06 | Class I | Error in labeling | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. | 930,813 units | |
| 2022-09-06 | Class I | Error in labeling | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. | 9,191,280 units | |
| 2022-09-06 | Class I | Error in labeling | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. | 42,954 units | |
| 2022-09-06 | Class I | Error in labeling | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. | 5,661,639 units | |
| 2022-09-06 | Class I | Error in labeling | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. | 6,237,558 units | |
| 2009-02-05 | Not classified | Nonconforming Material/Component | Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier PCA. | 449,585 units | 2012-07-05 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2003-09-29 | Not classified | Other | product does not contain built in exhalation port | 5293 units | 2004-03-01 |
| 2003-09-29 | Not classified | Other | product does not contain built in exhalation port | 5293 units | 2004-03-01 |
| 2003-09-29 | Not classified | Other | product does not contain built in exhalation port | 5293 units | 2004-03-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.