Identity
- Trade Name
- Hydrocleanse Wound Care Solution FDA UDI
- Generic Name
- Non-antimicrobial wound irrigation solution, multiple solute FDA UDI
- Model / Reference
- P-E1201T00 FDA UDI
Identifiers
- Catalog Number
- P-E1201T00 FDA UDI
- Primary DI / UDI-DI
- 00850015491108 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Non-antimicrobial wound irrigation solution, multiple solute FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
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
Dimensions & Sizes
- Size
- Total Volume — 250 Milliliter FDA UDI
Category: Non-antimicrobial wound irrigation solution, multiple solute
Hydrocleanse Wound Care Solution by Sonoma Pharmaceuticals, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-antimicrobial wound irrigation solution, multiple solute.
- CLEAR-LOCK CERAMIC — ORTHO ARCH COMPANY INC · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- Renovar Advanced — H R Pharmaceuticals, Inc. · U
- PrimaDerm® — Derma Sciences Canada, Inc · U
- CareOne — Ahold U.S.A., Inc. · U
- XPERIENCE — Next Science LLC · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sonoma Pharmaceuticals, Inc.
Sources (1)
- FDA UDI 7102148a-c00b-4efa-b677-d5630c20dbc4 34 fields · synced May 30, 2026