Medline MDS4001
Medline MDS4001 is a Class II device made by Medline Industries, Inc., cleared under FDA 510(k) K123882 on 14 Aug 2013 and listed in FDA GUDID since 2 Dec 2020 (UDI-DI 00888277361228), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00888277361228 | Date2 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123882 | Date14 Aug 2013 | StatusActive |
Official records
- AccessGUDID record 00888277361228
- FDA 510(k) database K123882
Across registries
- FDA 510(k) K123882 decided 14 Aug 2013 Active
- FDA GUDID UDI-DI 00888277361228 listed 2 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K123882
- Listed FDA GUDID 00888277361228
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medline
- Generic name
- Automatic-inflation electronic sphygmomanometer, portable, finger
- Model / Ref / Catalog
- MDS4001
- Primary DI / UDI-DI
- 00888277361228
- 510(k) Number
- FDA product code
- DXN
- GMDN term
- Automatic-inflation electronic sphygmomanometer, portable, finger
- Device class
- Class II
- Regulation number
- 870.1130
- GUDID distribution status
- In Commercial Distribution
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