Identity
- Trade Name
- Hydrofera Blue FDA UDI
- Generic Name
- Wound-nonadherent dressing, permeable, antimicrobial FDA UDI
- Device Name
- CLASSIC Antibacterial Foam Dressing with Moisture -Retentive Film FDA UDI
- Model / Reference
- HBRF4414 FDA UDI
- Description
- CLASSIC Antibacterial Foam Dressing with Moisture -Retentive Film FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20854827008138 FDA UDI
- 510(k) Number
- K013462 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound-nonadherent dressing, permeable, antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 4.0 Inch FDA UDIWidth — 4.0 Inch FDA UDI
Category: Wound-nonadherent dressing, permeable, antimicrobial
Hydrofera Blue by Hydrofera, Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound-nonadherent dressing, permeable, antimicrobial.
- Hydrofera Blue Ready - Border — HYDROFERA, LLC. · U
- Healqu — HEALQU LLC. · Class I
- TheraBond 3D antimicrobial barrier systems — ARGENTUM MEDICAL, LLC · U
- DeRoyal — DEROYAL INDUSTRIES, INC. · U
- DeRoyal — DEROYAL INDUSTRIES, INC. · U
- DeRoyal — DEROYAL INDUSTRIES, INC. · U
- Hydrofera Blue — HYDROFERA, LLC. · U
- DeRoyal — DEROYAL INDUSTRIES, INC. · U
Cleared under the same submission
K013462 also covers:
- Hydrofera Blue — HYDROFERA, LLC
- Hydrofera Blue — HYDROFERA, LLC
- Hydrofera Blue Classic — HYDROFERA, LLC
- Hydrofera Blue Classic — HYDROFERA, LLC
- Hydrofera Blue Classic — HYDROFERA, LLC
- Hydrofera Blue — HYDROFERA, LLC.
- Hydrofera Blue — HYDROFERA, LLC.
- Hydrofera Blue — HYDROFERA, LLC.
- Hydrofera Blue — HYDROFERA, LLC.
- Hydrofera Blue — HYDROFERA, LLC.
- Hydrofera Blue — HYDROFERA, LLC.
- Hydrofera Blue — HYDROFERA, LLC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Hydrofera, Llc
Sources (1)
- FDA UDI 6fa2fad6-68e7-4804-8691-efec461cde54 35 fields · synced Jun 8, 2026