Nonin
Reusable Adult Flex Pulse Oximeter Sensor and Model 8000JFW FlexiWrap® Single Use Sensor Wrap, 3 Meter
70manufacturers in China registered for this device type
129catalogue numbers in this listing
42510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (46), Jiangsu (7), Beijing (5). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Beijing Kingst Commercial & Trade Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Showing 12 of 70. All 70 manufacturers in China registered for Oximeter
Record
| Listed by | Nonin Medical, Inc., United States |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K092101 |
| Record published | 2016-09-13 |
| Record revised | 2021-11-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 158 °F; Storage environment temperature -40 to 70 °C |
| Packaging | Bag, box, clamshell, box of 24, bag of 5, box of 12 |
| Distribution end date | 2019-08-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LS1 PS | In distribution | |
| 8000SS | Small | In distribution |
| 8500 | In distribution | |
| 6500SA | Infant | In distribution |
| Capno RTC Cable | In distribution | |
| 9600NC-6 | In distribution | |
| 9600 | In distribution | |
| 8000AA-3 | Adult | In distribution |
| 8000J-WO | Adult | In distribution |
| 8604E-J | In distribution | |
| 6100CI | Infant | In distribution |
| 8000SL-3 | Large | In distribution |
| UNI-RA-0 | In distribution | |
| UNI-EXT-6 | In distribution | |
| 8000FI-20 | Pediatric | In distribution |
| 3150IW | In distribution | |
| 7500 | In distribution | |
| 6000CI | Infant | In distribution |
| 1000USB | In distribution | |
| 9500 | In distribution | |
| 8000AA-2 | Adult | In distribution |
| 7500 | In distribution | |
| 7500 Analog Cable | In distribution | |
| 9590 | Infant | In distribution |
| 8000SS-WO | Small | In distribution |
| 9700 | In distribution | |
| Pole Mount Clamp | In distribution | |
| 3150 WristOx2 | In distribution | |
| 9590 | Infant | In distribution |
| 8000Q2 | Greater than 88 lbs | In distribution |
| 3150 | In distribution | |
| 3240 | Infant | In distribution |
| 8000J-WO2 | Adult | In distribution |
| 7500SC | In distribution | |
| X-100EC-1 | In distribution | |
| 8000AA-DS | Adult | In distribution |
| 7500PS | In distribution | |
| 3013 CH | Adult | In distribution |
| 8000TW | Pediatric | In distribution |
| SenSmart Download Software | In distribution | |
| 1000USB-C | In distribution | |
| UNI-RA-0 | In distribution | |
| UNI-EXT-9 | In distribution | |
| 3240 | Pediatric | In distribution |
| 7500FO | In distribution | |
| 3013FH | Adult | In distribution |
| 9570 | Infant | In distribution |
| Lanyard. GO2 | In distribution | |
| 6000CA | Adult | In distribution |
| 7500SC | In distribution | |
| 8000FC-20 | Pediatric | In distribution |
| 8000FI-30 | Infant | In distribution |
| 8008J | Infant | In distribution |
| 9600NC-10X | In distribution | |
| 9550 | In distribution | |
| 6000CP | Pediatric | In distribution |
| 8000SS-WO2 | Small | In distribution |
| UNI-EXT-3 | In distribution | |
| 6100CA | Adult | In distribution |
| 6000CN | Neonate | In distribution |
| 9843 | In distribution | |
| 8000AP | Pediatric | In distribution |
| 8000AA | Adult | In distribution |
| 8100SM | Medium | In distribution |
| 7000N | Neonate | In distribution |
| 7500A/RJ-12 | In distribution | |
| 8000SM-3 | Medium | In distribution |
| 8000AA-WO2 | Adult | In distribution |
| 3150I | In distribution | |
| 2120 | In distribution | |
| 8000SL-WO2 | Large | In distribution |
| UNI-EXT-1 | In distribution | |
| 8100SS | Small | In distribution |
| 8000SS-3 | Small | In distribution |
| 3150 | In distribution | |
| 8000AP-WA | Pediatric | In distribution |
| 8000SL | Large | In distribution |
| 8000FW | Pediatric | In distribution |
| 9500 | In distribution | |
| 8000FC-30 | Pediatric | In distribution |
| AuxiliaryCabel | In distribution | |
| 7000P | Pediatric | In distribution |
| 8001J | Neonate | In distribution |
| 8000R | greater than 40kg | In distribution |
| 9600NC-10 | In distribution | |
| 6100CP | Pediatric | In distribution |
| 8000SM-WO2 | Medium | In distribution |
| 3100I-DS | In distribution | |
| 6100CN | Neonate | In distribution |
| 1062232 | Pediatric | In distribution |
| 2500 | In distribution | |
| 8000AP-3 | Adult | In distribution |
| 8000SL | Large | In distribution |
| 8001JFW | Neonate | In distribution |
| 3230 | Infant | In distribution |
| 8000AA-1 | Adult | In distribution |
| 7000I | Infant | In distribution |
| 8000J, 20CM | greater than 30 kilograms | In distribution |
| UNI-RA-3 | In distribution | |
| 9570 | Infant | In distribution |
| Model 3230 | In distribution | |
| 3150SC | In distribution | |
| 8500MB | In distribution | |
| 7500BP | In distribution | |
| 2500A | In distribution | |
| 8008JFW | Infant | In distribution |
| 3100I | In distribution | |
| 6500MA | Infant | In distribution |
| 9560 | In distribution | |
| 7000A | Adult | In distribution |
| 9550 | In distribution | |
| 8000J-3 | Adult | In distribution |
| 8000AA-WO | Adult | In distribution |
| 8000AA-WA | Adult | In distribution |
| 8000SM-WO | Medium | In distribution |
| 8000H | Infant | In distribution |
| 8000J | Adult | In distribution |
| 8000SM | Medium | In distribution |
| 8500M | In distribution | |
| 9590 | Infant | In distribution |
| 8800I | In distribution | |
| 9847 | In distribution | |
| 8000JFW | Adult | In distribution |
| 9590 | Infant | In distribution |
| 9570 | Infant | Withdrawn |
| 9570 | Infant | Withdrawn |
| NCell | Withdrawn | |
| 9570 | Infant | Withdrawn |
| 9570 | Infant | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 2,838 |
| APK | APK Technology Co., Ltd. | 2,678 |
| ChoiceMMed | Beijing Choice Electronic Technology Co., Ltd. | 151 |
| Nellcor | Covidien LP | 138 |
| Orantech | Orantech Inc. | 97 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 93 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Medichoice | Owens & Minor Distribution, Inc. | 62 |
| Caremed | Shenzhen Caremed Medical Technology Co., Ltd. | 55 |
| Sensoronics | Sensoronics Incorporated | 53 |
| Virtuox | Healthcare Logistics Systems | 36 |
| AMC | LifeSync Corporation | 36 |
Showing 12 of 1,063. All products under Oximeter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192900 | 2020-06-29 |
| K191403 | 2019-12-20 |
| K172625 | 2018-05-11 |
| K160231 | 2016-12-23 |
| K160865 | 2016-08-05 |
| K140785 | 2014-07-07 |
| K132402 | 2014-02-21 |
| K131021 | 2013-09-11 |
| K112843 | 2012-04-19 |
| K102350 | 2010-12-22 |
| K093853 | 2010-06-04 |
| K093306 | 2010-03-04 |
| K092101 | 2009-10-21 |
| K092678 | 2009-10-01 |
| K081285 | 2008-06-05 |
| K080255 | 2008-05-23 |
| K071415 | 2007-08-08 |
| K071285 | 2007-07-12 |
| K063752 | 2007-05-04 |
| K053130 | 2006-01-11 |
| K052669 | 2005-12-23 |
| K052829 | 2005-11-10 |
| K050056 | 2005-06-21 |
| K051107 | 2005-06-01 |
| K043359 | 2005-01-07 |
| K041156 | 2004-06-09 |
| K040589 | 2004-06-03 |
| K033307 | 2004-05-06 |
| K030668 | 2003-10-17 |
| K023044 | 2003-07-23 |
| K013319 | 2002-01-03 |
| K002690 | 2000-10-11 |
| K001930 | 2000-07-20 |
| K001085 | 2000-05-01 |
| K945290 | 1997-02-11 |
| K942248 | 1994-12-08 |
| K940463 | 1994-03-14 |
| K910001 | 1991-07-18 |
| K893221 | 1990-02-28 |
| K890033 | 1989-02-06 |
| K874947 | 1988-02-12 |
| K860051 | 1986-06-05 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nonin Medical, Inc. | 510(k) number | 2016-09-29 | Class II | Process control | Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated m | 15 (11 US; 4 OUS) | 2018-03-12 |
| Nonin Medical, Inc. | 510(k) number | 2014-11-25 | Class II | Nonconforming Material/Component | Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or il | 5892 (5452 US, 440 OUS) | 2015-09-01 |
| Nonin Medical, Inc. | 510(k) number | 2007-10-11 | Not classified | Error in labeling | Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500. | 240 | 2011-12-18 |
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.