Identity
- Trade Name
- BIOPATCH FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
- Device Name
- BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms. FDA UDI
- Model / Reference
- 10150 FDA UDI
- Description
- BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms. FDA UDI
Identifiers
- Catalog Number
- 10150 FDA UDI
- Primary DI / UDI-DI
- 10705031001107 FDA UDI
- 510(k) Number
- K003229 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, non-gel, 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
Yes
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
Category: Exudate-absorbent dressing, non-gel, antimicrobial
Biopatch by Ethicon Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent dressing, non-gel, antimicrobial.
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- Medline — MEDLINE INDUSTRIES, INC. · U
- NuMed Industries LLC. — Numed Industries, LLC · U
- Arthrex® — Arthrex, Inc. · U
- CalciCare — Hollister Incorporated · U
- ComfortFoam/Ag Border — DERMARITE INDUSTRIES LLC · U
Cleared under the same submission
K003229 also covers:
- BIOPATCH — Ethicon Inc.
- BIOPATCH — Ethicon Inc.
- BIOPATCH — Ethicon Inc.
- BIOPATCH — Ethicon Inc.
- BIOPATCH — Ethicon Inc.
- BioPatch® — Integra Lifesciences Corp.
- BioPatch® — Integra Lifesciences Corp.
- BioPatch® — Integra Lifesciences Corp.
- BioPatch™ — Integra Lifesciences Corp.
- BioPatch™ — Integra Lifesciences Corp.
- BioPatch™ — Integra Lifesciences Corp.
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
- Ethicon Inc.
Sources (1)
- FDA UDI 10119bb1-70ce-4538-8759-cdef4be9b5b8 37 fields · synced May 30, 2026