Hydrofera Blue HBRF4414
Hydrofera Blue HBRF4414 is a device classified as Unclassified made by Hydrofera, LLC, cleared under FDA 510(k) K013462 on 11 Jan 2002 and listed in FDA GUDID since 1 Jun 2018 (UDI-DI 20854827008138), 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 | Number20854827008138 | Date1 Jun 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013462 | Date11 Jan 2002 | StatusActive |
Official records
- AccessGUDID record 20854827008138
- FDA 510(k) database K013462
Across registries
- FDA 510(k) K013462 decided 11 Jan 2002 Active
- FDA GUDID UDI-DI 20854827008138 listed 1 Jun 2018 Listed
Timeline
- Cleared FDA 510(k) K013462
- Listed FDA GUDID 20854827008138
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- Withdrawn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
- HBRF4414
- Primary DI / UDI-DI
- 20854827008138
- 510(k) Number
- FDA product code
- FRO
- GMDN term
- Wound-nonadherent dressing, permeable, antimicrobial
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- Size
- Height — 4.0 InchWidth — 4.0 Inch
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