BluWing MER 1925
BluWing MER 1925 is a Class II device made by Mercedes Medical LLC, cleared under FDA 510(k) K163093 on 14 Mar 2017 and listed in FDA GUDID since 1 Jul 2017 (UDI-DI 00850011007242), 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 | Number00850011007242 | Date1 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163093 | Date14 Mar 2017 | StatusActive |
Official records
- AccessGUDID record 00850011007242
- FDA 510(k) database K163093
Across registries
- FDA 510(k) K163093 decided 14 Mar 2017 Active
- FDA GUDID UDI-DI 00850011007242 listed 1 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K163093
- Listed FDA GUDID 00850011007242
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BluWing
- Generic name
- Venous butterfly needle/set
- Model / Ref / Catalog
- MER 1925
- Primary DI / UDI-DI
- 00850011007242
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Venous butterfly needle/set
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
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