Identity
- Trade Name
- PVA Foam Kit Large EUDAMEDFDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- XLR8 PVA Foam Kit Large EUDAMEDThe Genadyne PVA Foam Kit Large consists of a XLR8 Port, two XLR8 Transparent Film and a White PVA Foam Large. Each component are packaged, sealed and sterilized individually and then bagged into a kit. FDA UDI
- Model / Reference
- PVA-LFOAM1 EUDAMEDFDA UDI
- Description
- The Genadyne PVA Foam Kit Large consists of a XLR8 Port, two XLR8 Transparent Film and a White PVA Foam Large. Each component are packaged, sealed and sterilized individually and then bagged into a kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849405025139 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849405025139 EUDAMED
- 510(k) Number
- K142646 FDA UDI
- FDA Product Code
- OMP FDA UDI
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
- GMDN Term
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
PVA Foam Kit Large by Genadyne Biotechnologies, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
- ALIVIOVISCO — LIDERMED S.A. · Class I
- Gamgee BP – Non-sterile 45x45cm — Robinson Healthcare Ltd · Class I
- Herpatch — Sylphar nv · Class IIa
- N1 Psoriasis Intens Crème — PK Benelux BV · Class IIa
- Polyurethane Foam Dressing — Shandong Shinrise Medical Supplies Co., Ltd. · Class IIa
- Holland & Barrett Eczeem crème — PK Benelux BV · Class IIa
- Paraffin gauze dressings — Roosin Medical Co., Ltd. · Class IIa
- Innomed — Zhejiang Longterm Medical Technology Co., Ltd. · Class IIb
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
Sources (2)
- FDA UDI 1b1f1dd4-1d92-4d4c-850f-8447d6e465b1 34 fields · synced Aug 1, 2026
- EUDAMED 6e079f9e-ecb2-474c-bfd4-b3339d9d594a 61 fields · synced Aug 1, 2026