Nellcor
SpO2 Sensor, Multi-site Reusable;Sensor; (10) Adult-Neonatal Foam Sensor Wraps; (10) Pediatric-Infant Foam Sensor Wraps; (10) Adult/Neonatal Adhesive Sensor Wraps; (10) Pediatric/Infant…
SpO2 Sensor, Multi-site Reusable;Sensor; (10) Adult-Neonatal Foam Sensor Wraps; (10) Pediatric-Infant Foam Sensor Wraps; (10) Adult/Neonatal Adhesive Sensor Wraps; (10) Pediatric/Infant Adhesive Sensor Wraps
70manufacturers in China registered for this device type
138catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| 510(k) | K012891 |
| Record published | 2016-09-24 |
| Record revised | 2026-02-20 (version 18) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment humidity 15 to 95 % RH; Handling environment temperature 0 to 50 °C; Storage environment temperature -40 to 70 °C; Storage environment humidity 15 to 95 % RH |
| Packaging | Case of 24, case of 50, case of 20, case of 96, pack_or_inner_pack of 6, case of 25 |
| Sizes | Length 4 to 10 ft; length 1.2 to 3.6 m; length 305 cm |
| Distribution end date | 2026-02-26 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MAXAL | Patient Weight, >30, KG; | In distribution | |
| FLEXMAX-P-HC | Weight, >20, KG; | In distribution | |
| 902-I | Patient Weight, 3 – 20, KG; | In distribution | |
| PMSW-RR-V2.0 | In distribution | ||
| DLPM10N | In distribution | ||
| MAXA-NS | Patient Weight, >30, KG; | In distribution | |
| MAXP | Patient Weight, 10-50, KG; | In distribution | |
| MAXAJ | Patient Weight, >30, KG; | In distribution | |
| FLEXMAX | Weight, >20, KG; | In distribution | |
| MAXNI | Patient Weight,<3,Kilogram;Patient Weight,>40,Kilogram; | In distribution | |
| DOC4 | Length 4 ft | In distribution | |
| MC10 | Length 10 ft | In distribution | |
| FLEXMAX-HC | Weight, >20, KG; | In distribution | |
| GR101704 | In distribution | ||
| MAXPAC | In distribution | ||
| DSGR101704 | In distribution | ||
| PMC10GE360N | Length 3.0 m | In distribution | |
| DS100A | Patient Weight, >40, KG; | In distribution | |
| MAXPI | Patient Weight, 10-50, KG; | In distribution | |
| PMC10GE120N | Length 1.8 m | In distribution | |
| MAXRJ | Patient Weight, >50, KG; | In distribution | |
| 10004954 | Size,greater than or equal to 10,Kilogram; | In distribution | |
| FLEXMAX-P | Weight, >20, KG; | In distribution | |
| PMC10GE120N | Length 1.2 m | In distribution | |
| MAXNW | Weight, >40, KG; | In distribution | |
| MAXALI | Patient Weight, >30, KG; | In distribution | |
| DEC4 | Length 4 ft | In distribution | |
| DOC10 | Length 10 ft | In distribution | |
| DSN85 | In distribution | ||
| MAXFASTI | Patient Weight, Greater than or Equal to 10, KG; | In distribution | |
| PMC10GE120N | Length 1.8 m | In distribution | |
| N65 | In distribution | ||
| PM10N | In distribution | ||
| 10005941-SG | Power,100-240,Volts; | In distribution | |
| MAXIJ | Patient Weight, 3-20, KG; | In distribution | |
| MAXP-NS | Patient Weight, 10-50, KG; | In distribution | |
| MAXPACI | In distribution | ||
| 10083058 | In distribution | ||
| SC-NEO-I | Patient Weight, 1.5-5, KG; | In distribution | |
| OXI-A/N | Patient Weight, <3 >40, KG; | In distribution | |
| DL10005941 | In distribution | ||
| MAXALJ | Patient Weight, >30, KG; | In distribution | |
| MAXFASTI | Patient Weight, Greater than or Equal to 10, KG; | In distribution | |
| DEC8 | Length 8 ft | In distribution | |
| 901-A | Patient Weight, >30, KG; | In distribution | |
| MAXFAST | Patient Weight, Greater than or Equal to 10, KG; | In distribution | |
| MAXNJ | Patient Weight,<3,Kilogram;Patient Weight,>40,Kilogram; | In distribution | |
| 10005063 | In distribution | ||
| 867193 | In distribution | ||
| MAXR | Patient Weight, >50, KG; | In distribution | |
| PM10N-W | In distribution | ||
| 10076644 | In distribution | ||
| PMC10N-SF | Length 305 cm | In distribution | |
| SC-PR-I | Patient Weight, <1.5, KG; | In distribution | |
| SC-A-I | Patient Weight, >40, KG; | In distribution | |
| MAXA | Patient Weight, >30, KG; | In distribution | |
| MAXN-NS | Patient Weight,<3,Kilogram;Patient Weight,>40,Kilogram; | In distribution | |
| PMC10NFH-GE | In distribution | ||
| MAXN | Patient Weight,<3,Kilogram;Patient Weight,>40,Kilogram; | In distribution | |
| DS10005941 | In distribution | ||
| 903-P | Patient Weight, 10 – 50, KG; | In distribution | |
| SC-NEO | Patient Weight, 1.5-5, KG; | In distribution | |
| DLN560 | In distribution | ||
| 10093313 | In distribution | ||
| MAXAI | Patient Weight, >30, KG; | In distribution | |
| DS100A-1 | Patient Weight, >40, KG; | In distribution | |
| MAXI | Patient Weight, 3-20, KG; | In distribution | |
| PI | Patient Weight, 10-50, KG; | In distribution | |
| MAXRI | Patient Weight, >50, KG; | In distribution | |
| DSPM10N | In distribution | ||
| 10076645 | In distribution | ||
| SC-A | Patient Weight, >40, KG; | In distribution | |
| DLPM100N | In distribution | ||
| SC-PR | Patient Weight, <1.5, KG; | In distribution | |
| MAXFAST | Patient Weight, Greater than or Equal to 10, KG; | In distribution | |
| 904-N | Patient Weight,<3,Kilogram;Patient Weight,>40,Kilogram; | In distribution | |
| OXI-P/I | Patient Weight, 30-40, KG; | In distribution | |
| POSEY | Product Size, One Size, NA; | 12 | In distribution |
| MAXPJ | Patient Weight, 10-50, KG; | In distribution | |
| N600x-A | In distribution | ||
| DSN600X | In distribution | ||
| DLPM1000N | In distribution | ||
| D-YSE | Patient Weight, >30, KG; | In distribution | |
| MAXII | Patient Weight, 3-20, KG; | In distribution | |
| MAXI-NS | Patient Weight, 3-20, KG; | In distribution | |
| RS10 | Patient Weight, >40, KG; | In distribution | |
| D-YSPD | Patient Weight, 3-40, KG; | In distribution | |
| MAXPACAI | In distribution | ||
| D-YS | Patient Weight, >1, KG; | In distribution | |
| DLN85 | In distribution | ||
| PMC10GE360N | Length 3.6 m | In distribution | |
| DLN600X-A | In distribution | ||
| PMC10GE360N | Length 3.0 m | In distribution | |
| DLN600X | In distribution | ||
| MAXAL-NS | Patient Weight, >30, KG; | In distribution | |
| GR101743 | In distribution | ||
| PMC10NCH-GE | In distribution | ||
| I20 | Patient Weight, 3-20, KG; | In distribution | |
| PM100N | Power,100-240,Volts; | In distribution | |
| 10005941 | Power,100-240,Volts; | In distribution | |
| DECU10 | Length 10 ft | In distribution | |
| OC-3 | Withdrawn | ||
| N25 | Patient Weight, < 3 KG, >40 KG; | Withdrawn | |
| DSN65 | Withdrawn | ||
| PMC10UB305N | Length 305 cm | Withdrawn | |
| N600X | Withdrawn | ||
| MCU10-10 | 10 | Withdrawn | |
| DSPM10N-W | Withdrawn | ||
| N | Patient Weight,<3,Kilogram;Patient Weight,>40,Kilogram; | Withdrawn | |
| P | Patient Weight, 10-50, KG; | Withdrawn | |
| I | Patient Weight, 3-20, KG; | Withdrawn | |
| DSN560 | Withdrawn | ||
| N65-1 | Withdrawn | ||
| DSGR101704-RR | Withdrawn | ||
| DLPM10N-W | Withdrawn | ||
| DLGR101704 | Withdrawn | ||
| D25L | Patient Weight, >30, KG; | Withdrawn | |
| DL10076644 | Withdrawn | ||
| DLN65 | Withdrawn | ||
| N600X-1A | Withdrawn | ||
| DSPM1000N-RR | Withdrawn | ||
| NI | Patient Weight,<3,Kilogram;Patient Weight,>40,Kilogram; | Withdrawn | |
| D20 | Patient Weight, 10-50, KG; | Withdrawn | |
| PM1000N-RR | Withdrawn | ||
| GR101704-RR | Withdrawn | ||
| DSPM1000N | Withdrawn | ||
| 10083058-RFB | Withdrawn | ||
| DLGR101704-RR | Withdrawn | ||
| N600X-1 | Withdrawn | ||
| DLPM1000N-RR | Withdrawn | ||
| AI | Patient Weight, >30, KG; | Withdrawn | |
| DLN65 | Withdrawn | ||
| DSN600X-A | Withdrawn | ||
| D25 | Patient Weight, >30, KG; | Withdrawn | |
| PM1000N | Withdrawn | ||
| DSPM100N | Withdrawn | ||
| A | Patient Weight, >30, KG; | Withdrawn | |
| DS10076644 | 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 |
| Nonin | Nonin Medical, Inc. | 129 |
| 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
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2025-06-23 | Class II | Labeling design | Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator’s manual: 1)For patient Safety don’t silence/d | 264,790 | |
| Covidien | 510(k) number | 2016-12-16 | Class II | Process control | Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex. | 7453 Units | 2018-12-04 |
| Covidien | 510(k) number | 2015-06-29 | Class II | Device Design | Potential missing segments on the display that can result in misinterpretation of data. | 211,426 units | 2017-11-03 |
| Covidien | 510(k) number | 2015-06-29 | Class II | Device Design | Potential missing segments on the display that can result in misinterpretation of data. | 105,831 units | 2017-11-03 |
| Covidien | 510(k) number | 2004-10-18 | Not classified | Other | The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency. | 42,451 units | 2006-05-15 |
| Covidien | 510(k) number | 2004-10-18 | Not classified | Other | The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency. | 5,344 units | 2006-05-15 |
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.