Hydrofera Blue HBRB6080E
Hydrofera Blue HBRB6080E is a device classified as Unclassified made by Hydrofera, LLC, cleared under FDA 510(k) K190268 on 6 Nov 2019 and listed in FDA GUDID since 22 Nov 2024 (UDI-DI 00854827008677), active as of 22 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 | Number00854827008677 | Date22 Nov 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190268 | Date6 Nov 2019 | StatusActive |
Official records
- AccessGUDID record 00854827008677
- FDA 510(k) database K190268
Across registries
- FDA 510(k) K190268 decided 6 Nov 2019 Active
- FDA GUDID UDI-DI 00854827008677 listed 22 Nov 2024 Listed
Timeline
- Cleared FDA 510(k) K190268
- Listed FDA GUDID 00854827008677
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hydrofera Blue
- Generic name
- Wound-nonadherent dressing, permeable, antimicrobial
- Model / reference
- HBRB6080E
- Primary DI / UDI-DI
- 00854827008677
- 510(k) Number
- FDA product code
- FRO
- GMDN term
- Wound-nonadherent dressing, permeable, antimicrobial
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 6 InchWidth — 8 Inch
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