Identity
- Trade Name
- ViveCare FDA UDI
- Generic Name
- Petrolatum woven gauze pad FDA UDI
- Device Name
- Xeroform Petrolatum Dressing (1x8") 50ct FDA UDI
- Model / Reference
- RHB3028YEL18CT50 FDA UDI
- Description
- Xeroform Petrolatum Dressing (1x8") 50ct FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810113578088 FDA UDI
- 510(k) Number
- K181478 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Petrolatum woven gauze pad 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Petrolatum woven gauze pad
ViveCare by Vive Health Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Petrolatum woven gauze pad.
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · U
- PETROLATUM GAUZE® — Derma Sciences Canada, Inc · Class II
- Vitale — CellEra, LLC · Class I
- Polynew — Roosin Medical Co., Ltd. · U
- Simpurity — SAFE N SIMPLE LLC · Class I
- Vitale — CellEra, LLC · Class I
- PETROLATUM GAUZE® — Derma Sciences Canada, Inc · Class II
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · U
Cleared under the same submission
K181478 also covers:
- Durma+ Petrolatum Gauze Dressing, 1" x 8", Neutral Wound, Dressing — Dynarex Corp.
- Dr.Med — Roosin Medical Co., Ltd.
- Dr.Med — Roosin Medical Co., Ltd.
- Dr.Med — Roosin Medical Co., Ltd.
- Dr.Med — Roosin Medical Co., Ltd.
- Polynew — Roosin Medical Co., Ltd.
- Polynew — Roosin Medical Co., Ltd.
- Polynew — Roosin Medical Co., Ltd.
- Polynew — Roosin Medical Co., Ltd.
- ViveCare — VIVE HEALTH LLC
- ViveCare — VIVE HEALTH LLC
- ViveCare — VIVE HEALTH 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
- Vive Health Llc
Sources (1)
- FDA UDI 4a57c6f5-5904-473e-ba5b-503eb12e8c14 34 fields · synced May 30, 2026