Nellcor 10005063
by Covidien LP
Nellcor 10005063 is a Class II device made by Covidien LP, cleared under FDA 510(k) K904039 on 27 Dec 1990 and listed in FDA GUDID since 12 Sep 2017 (UDI-DI 30884521080557), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30884521080557 | Date12 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK904039 | Date27 Dec 1990 | StatusActive |
Official records
- AccessGUDID record 30884521080557
- FDA 510(k) database K904039
Across registries
- FDA 510(k) K904039 decided 27 Dec 1990 Active
- FDA GUDID UDI-DI 30884521080557 listed 12 Sep 2017 Listed
Recalls
-
- Terminated Z-1125-2017
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Timeline
- Cleared FDA 510(k) K904039
- Recall initiated FDA recalls Z-1125-2017
- Listed FDA GUDID 30884521080557
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nellcor
- Generic name
- Pulse oximeter probe, single-use
- Model / reference
- 10005063
- Primary DI / UDI-DI
- 30884521080557
- 510(k) Number
- FDA product code
- DQA
- GMDN term
- Pulse oximeter probe, single-use
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Pulse oximeter probe, single-use.
- SpO2.COM® adult SpO2 disposable sensor 1774 by MASIMO CORPORATION
- Infant Flexiwrap Sensor 4774-000 by Nonin Medical, Inc.
- Spo2 sensor SS-009RB-PS36 by Orantech Inc.
- RUI RSY003DN by Beijing Rongrui-Century Science & Technology Co., Ltd.
- Spo2 sensor SS-124-AS30 by Orantech Inc.
- SZcaremed C803-01X by Shenzhen Caremed Medical Technology Co., Ltd.
- SpO2.COM® pediatric SpO2 disposable sensor 1775 by MASIMO CORPORATION
- RUI RSA001DA-H100 by Beijing Rongrui-Century Science & Technology Co., Ltd.
- 8000SS 6837-800 by Nonin Medical, Inc.
- Reusable Soft SpO2 Sensor FMT-RAS(B)/CHC-LR by METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ