Hmg 1
by Hartman Medical Group LLC 4 variants
Hmg 1 is a Class II device made by Hartman Medical Group LLC, cleared under FDA 510(k) K172763 on 4 Jun 2018 and listed in FDA GUDID since 25 Apr 2023 (UDI-DI 20850048235018), active as of 8 Nov 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 | Number20850048235018 | Date25 Apr 2023 | StatusListed |
| United States | FDA 510(k) | NumberK172763 | Date4 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 20850048235018
- FDA 510(k) database K172763
Across registries
- FDA 510(k) K172763 decided 4 Jun 2018 Active
- FDA GUDID UDI-DI 20850048235018 listed 25 Apr 2023 Listed
Timeline
- Cleared FDA 510(k) K172763
- Listed FDA GUDID 20850048235018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hmg
- Generic name
- Blood collection set, noninvasive
- Model / reference
- 1
- Primary DI / UDI-DI
- 20850048235018
- 510(k) Number
- FDA product code
- JKA
- GMDN term
- Blood collection set, noninvasive
- Device class
- Class II
- Regulation number
- 862.1675
- GUDID distribution status
- In Commercial Distribution
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