Medline OGBCS23GT
Medline OGBCS23GT is a Class II device made by Medline Industries, Inc., cleared under FDA 510(k) K151991 and listed in FDA GUDID since 7 May 2025 (UDI-DI 10197344112111), 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 | Number10197344112111 | Date7 May 2025 | StatusListed |
| United States | FDA 510(k) | NumberK151991 | Date— | StatusActive |
Official records
- AccessGUDID record 10197344112111
- FDA 510(k) database K151991
Across registries
- FDA 510(k) K151991 Active
- FDA GUDID UDI-DI 10197344112111 listed 7 May 2025 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medline
- Generic name
- Blood collection set, invasive
- Model / Ref / Catalog
- OGBCS23GT
- Primary DI / UDI-DI
- 10197344112111
- 510(k) Number
- FDA product code
- FPA
- GMDN term
- Blood collection set, invasive
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Blood collection set, invasive.