Puritan Bennett
Nellcor Puritan Bennett D/X7 Single Patient Use Expiratory Filter for 700 Series Ventilators
8manufacturers in China registered for this device type
285catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 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 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| 510(k) | K002686 |
| Record published | 2015-08-28 |
| Record revised | 2025-06-24 (version 18) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Handling environment temperature 50 to 104 °F; Storage environment temperature -4 to 122 °F; Handling environment atmospheric pressure 70 to 106 KiloPascal; Special storage condition: This Side Up;Keep Dry;Fragile |
| Packaging | Case of 9999, case of 12, case of 10, case of 30, case of 50, case of 6 |
| Distribution end date | 2025-06-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 980X3JADIJJ | In distribution | ||
| 980X1DENISS | In distribution | ||
| 980X3ENASAA | In distribution | ||
| 10084332 | In distribution | ||
| Y-6463 | In distribution | ||
| 980X1NOAIQC | In distribution | ||
| 980U1FRDICU | In distribution | ||
| 10083943 | In distribution | ||
| 10035176 | In distribution | ||
| 980S3ESDIUC | In distribution | ||
| 980X3SVAIQC | In distribution | ||
| 980X1DEDISS | In distribution | ||
| 980U3ENASAA | In distribution | ||
| 980X3FRAIQC | In distribution | ||
| 980X1PLDIPC | In distribution | ||
| 980X1ENDIPC | In distribution | ||
| 980U1ESDIUA | In distribution | ||
| 980U3ESDIUU | In distribution | ||
| G-060525-00 | In distribution | ||
| 980X3RUDIEC | In distribution | ||
| 4-840220AIQC-EN | In distribution | ||
| 4-076887-00 | In distribution | ||
| 10084331 | In distribution | ||
| 980X3DAAIQC | In distribution | ||
| 980X1ENDRAC | In distribution | ||
| 980X1ESDIEC | In distribution | ||
| 980X1ENDISS | In distribution | ||
| 980X1ITDIEC | In distribution | ||
| 10141914 | 6 | In distribution | |
| 980X3PLDIPC | In distribution | ||
| 980N3ENDICU | In distribution | ||
| 980X3RODRAC | In distribution | ||
| 980X3ELAIQC | In distribution | ||
| 980X3BGDRAC | In distribution | ||
| 980X1ENASAA | In distribution | ||
| 980X1JADIJJ | In distribution | ||
| 980IESYNC | In distribution | ||
| 980X3DEDISS | In distribution | ||
| 980X1DEDRAC | In distribution | ||
| 980X1FRDICU | In distribution | ||
| 980X1SVAIQC | In distribution | ||
| 4-015254-00 | In distribution | ||
| 4-006308-00 | In distribution | ||
| 980NIVPLUS | In distribution | ||
| 10049995 | In distribution | ||
| 980X1ENNISA | In distribution | ||
| 980X1SKNISC | In distribution | ||
| 980S3ESDIUA | In distribution | ||
| 980S3ENASAA | In distribution | ||
| 10086042 | Watt-Hour,189,W;Electric Current,25.2,V; | In distribution | |
| 980X1ENDIJI | In distribution | ||
| 980X1ELAIQC | In distribution | ||
| 980X3ESDIEC | In distribution | ||
| 980X3ENDIUU-RMF | In distribution | ||
| 980HFO2T-US | In distribution | ||
| 980X1ENDIUU | In distribution | ||
| 980X3ENDIUU | In distribution | ||
| 980X1CSNISC | In distribution | ||
| 4-010793-00 | 12 | In distribution | |
| 10035086 | In distribution | ||
| 980S3ENDIUU | In distribution | ||
| 10049998 | In distribution | ||
| 980X3TRDRAC | In distribution | ||
| 980X1ENAIQC | In distribution | ||
| 980X3FIAIQC | In distribution | ||
| 980X1ENDIPB | In distribution | ||
| 980X1ENDIAC | In distribution | ||
| 980X3PTDIPC | In distribution | ||
| 980X1ITDISS | In distribution | ||
| 980X3FRDISS | In distribution | ||
| 980A1ENNISB | In distribution | ||
| 980X1DAAIQC | In distribution | ||
| G-060526-00 | In distribution | ||
| 980X3ENDIJI | In distribution | ||
| 980X1RODRAC | In distribution | ||
| 980X1ENDIUC | In distribution | ||
| 10043551 | In distribution | ||
| 10097559 | In distribution | ||
| 980S1ENDIUU | In distribution | ||
| 4-074647-00 | In distribution | ||
| 10045581 | In distribution | ||
| 980U1ENDICU | In distribution | ||
| 980X3ENAIQC | In distribution | ||
| 980X1SLDRAC | In distribution | ||
| 10086048 | In distribution | ||
| 980X1FIAIQC | In distribution | ||
| 10086051 | In distribution | ||
| 980X1FRDISS | In distribution | ||
| 980NEB | In distribution | ||
| 980X1TRDRAC | In distribution | ||
| 980X1HRDRAC | In distribution | ||
| 980X1PLDRAC | In distribution | ||
| 980X1BGDRAC | In distribution | ||
| 980U1ENASAA | In distribution | ||
| 980X3ENDISS | In distribution | ||
| 980X3PLDRAC | In distribution | ||
| 980X1PTDIPC | In distribution | ||
| 980X3NLDRAC | In distribution | ||
| 980NEOFLT | In distribution | ||
| 980X3ENDIPB | In distribution | ||
| 10114989 | In distribution | ||
| 10049978 | In distribution | ||
| 980HFO2T | In distribution | ||
| 980S1ENDICU | In distribution | ||
| 980X3ENDIPC | In distribution | ||
| 4-070305-00 | In distribution | ||
| 980S1ENASAA | In distribution | ||
| Y-6464 | In distribution | ||
| 980X3ENDRAC | In distribution | ||
| 10095100 | In distribution | ||
| 980X1ENNISB | In distribution | ||
| 4-011905-00 | In distribution | ||
| 980U1PTDIUNA | In distribution | ||
| 980X1SRDRAC | In distribution | ||
| 980X3SRDRAC | In distribution | ||
| 980U3ENDIUU-LA | In distribution | ||
| 980X3RUDRAC | In distribution | ||
| 980X3HUNISC | In distribution | ||
| 980X3ITDISS | In distribution | ||
| 980IESYNC-US | In distribution | ||
| 980U1ESDIUC | In distribution | ||
| 980X3CSNISC | In distribution | ||
| 980S1PTDIUNA | In distribution | ||
| 4-006306-00 | In distribution | ||
| G-060525-00 | In distribution | ||
| 980X3ITDIEC | In distribution | ||
| 980U3ENDIUU | In distribution | ||
| 980X1ENDIUU-RMF | In distribution | ||
| 980X1RUDRAC | In distribution | ||
| 980X1HUNISC | In distribution | ||
| 980N3ENDIUU | In distribution | ||
| 4-074613-00 | 250 | In distribution | |
| 980X1FRAIQC | In distribution | ||
| 980X1RUDIEC | In distribution | ||
| 980S3ESDIUU | In distribution | ||
| 10045584 | In distribution | ||
| 980X3SKNISC | In distribution | ||
| 10045577 | In distribution | ||
| 4-076325-00 | In distribution | ||
| 10087409 | In distribution | ||
| 980X1NLDRAC | In distribution | ||
| 980X1ENDIPP | In distribution | ||
| 980X3DEDRAC | In distribution | ||
| 4-076330-00 | In distribution | ||
| 980X2ENDIUU | In distribution | ||
| 980X3ENDIPP | In distribution | ||
| 980U3PTDIUNA | In distribution | ||
| 980X3SLDRAC | In distribution | ||
| 980S1ENDICU | In distribution | ||
| 10045577 | In distribution | ||
| 10049998-RFB | In distribution | ||
| 980NIVPLUS-US | In distribution | ||
| 10045572 | In distribution | ||
| 980X1ENDIUA | In distribution | ||
| 10083942 | In distribution | ||
| 10053298 | In distribution | ||
| 980U1ENDIUU | In distribution | ||
| 980X3HRDRAC | In distribution | ||
| 980X3ENNISB | In distribution | ||
| 980X3NOAIQC | In distribution | ||
| 4-840220DIUU-PR | Withdrawn | ||
| 4-840220DISS-FR | Withdrawn | ||
| G-760220DIUE-PL | Withdrawn | ||
| 980X3ENDICU | Withdrawn | ||
| 980N3ESDIUA | Withdrawn | ||
| 4-840220DIJA-EN | Withdrawn | ||
| 4-840220DIPB-EN | Withdrawn | ||
| 980N1FRDICU | Withdrawn | ||
| G-760110DIUU-JP | Withdrawn | ||
| 4-840220DISS-EN | Withdrawn | ||
| 980X1ENDICU | Withdrawn | ||
| G-760220DIUR-EN | Withdrawn | ||
| 980N3ENDIUU-LA | Withdrawn | ||
| G-061949-00 | Withdrawn | ||
| 10049980 | Withdrawn | ||
| 980S3PTDIUNA | Withdrawn | ||
| 980N3ESDIUU | Withdrawn | ||
| 4-840220NIHC-EN | Withdrawn | ||
| 10035878 | Withdrawn | ||
| 980S1ESDIUU | Withdrawn | ||
| 10122271 | Withdrawn | ||
| 4-840220DIPC-PL | Withdrawn | ||
| 4-840120DIJJ-NJ | Withdrawn | ||
| 980U3ESDIUA | Withdrawn | ||
| G-760110DIUU-TW | Withdrawn | ||
| 980S3ENDIUU-LA | Withdrawn | ||
| 4-840220DIUB-EN | Withdrawn | ||
| 4-840120DICU-EN | Withdrawn | ||
| G-760220NISB-EN | Withdrawn | ||
| 980N1ENDIUU-LA | Withdrawn | ||
| 4-076326-00 | Withdrawn | ||
| 980N1ESDIUA | Withdrawn | ||
| 980S1ESDIUC | Withdrawn | ||
| 4-076331-00 | Withdrawn | ||
| 4-076329-00 | Withdrawn | ||
| 10049979 | Withdrawn | ||
| 4-840220NISS-GR | Withdrawn | ||
| 4-840120DIUU-SP | Withdrawn | ||
| 4-840220DIUA-SP | Withdrawn | ||
| 4-840220NISB-EN | Withdrawn | ||
| 980U3FRDICU | Withdrawn | ||
| 980N3ENASAA | Withdrawn | ||
| 4-840220DIUA-EN | Withdrawn | ||
| G-740220DIUE-PR | Withdrawn | ||
| 10047120 | Withdrawn | ||
| 980S1ENDIUU-LA | Withdrawn | ||
| 980N1ENASAA | Withdrawn | ||
| 4-840220DIPC-PR | Withdrawn | ||
| 4-840220DIUC-SP | Withdrawn | ||
| 980X3FRDICU | Withdrawn | ||
| 980N1ESDIUU | Withdrawn | ||
| 4-076447-00 | Withdrawn | ||
| G-760220DIUE-RS | Withdrawn | ||
| 4-840120DIUU-EN | Withdrawn | ||
| 4-076322-00 | Withdrawn | ||
| 4-840220DIEC-IT | Withdrawn | ||
| 980N3PTDIUNA | Withdrawn | ||
| 980S2ENDIUU | Withdrawn | ||
| 4-840220DIEC-EN | Withdrawn | ||
| 4-840220NISC-FR | Withdrawn | ||
| 980S1ESDIUA | Withdrawn | ||
| 4-840220DIAU-EN | Withdrawn | ||
| 10122274 | Withdrawn | ||
| 980N3FRDICU | Withdrawn | ||
| 4-840120DIJJ-JP | Withdrawn | ||
| 4-840220AIQC-FR | Withdrawn | ||
| 980N1ESDIUC | Withdrawn | ||
| 10051467 | Withdrawn | ||
| 10051458 | Withdrawn | ||
| 4-840220DIEC-SP | Withdrawn | ||
| 4-840120DIUU-US | Withdrawn | ||
| 4-840120DIUU-PR | Withdrawn | ||
| 980U3ENDICU | Withdrawn | ||
| G-760220DIUA-EN | Withdrawn | ||
| 4-076323-00 | Withdrawn | ||
| 10050000 | Withdrawn | ||
| 4-840220ASAA-EN | Withdrawn | ||
| 4-840220NISC-EN | Withdrawn | ||
| 980N1ENDICU | Withdrawn | ||
| 980A3ENNISB | Withdrawn | ||
| 4-840220DIAC-EN | Withdrawn | ||
| G-061792-00 | Withdrawn | ||
| 980U2ENDIUU | Withdrawn | ||
| 980N1ENDIUU | Withdrawn | ||
| 980N2ENDIUU | Withdrawn | ||
| 4-076324-00 | Withdrawn | ||
| 4-840220DIEC-RS | Withdrawn | ||
| 980N1PTDIUNA | Withdrawn | ||
| 4-078140-00 | Withdrawn | ||
| 4-840220DIJI-EN | Withdrawn |
Showing 250 of 285 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
| Vent | Zoll Medical Corporation | 32 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151252 | 2016-03-29 |
Recalls Naming This Product
20 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2021-11-04 | Class I | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. | 278 total | 2024-07-09 |
| Covidien | UDI-DI | 2020-10-16 | Class II | Device Design | In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm, | 23,329 units total:. US 12,956; OUS 10,405 | |
| Covidien | 510(k) number | 2013-01-25 | Class II | Labeling Change Control | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett” 840, and PN, G-062010-00, used in Puritan Bennett” 740, and760 ventilator systems. The Operators | 70,160 | 2014-11-24 |
| Covidien | 510(k) number | 2013-01-25 | Class II | Labeling Change Control | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett” 840, and PN, G-062010-00, used in Puritan Bennett” 740, and760 ventilator systems. The Operators | 7,959 | 2014-11-24 |
| Nellcor Puritan Bennett, Inc. | 510(k) number | 2004-12-17 | Not classified | Other | Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss. | 13,010 worldwide, 3,948 in USA and territories. | 2008-01-23 |
| Nellcor Puritan Bennett, Inc. | 510(k) number | 2004-12-16 | Not classified | Other | Wires on battery may loosen causing disconnection. | 6642 (3680 in vents and 2962 as replacements) | 2008-01-23 |
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.