Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container

FDA UDI

Class U (US FDA UDI)

by Urgo Medical North America, LLC

Identity

Trade Name: Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container FDA UDI
Generic Name: Antimicrobial wound irrigation solution FDA UDI
Device Name: Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 1 L (34 fl oz) size with the instillation cap. FDA UDI
Model / Reference: 00323 FDA UDI
Description: Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 1 L (34 fl oz) size with the instillation cap. FDA UDI

Identifiers

Catalog Number: 00323 FDA UDI
Primary DI / UDI-DI: 00851383003238 FDA UDI
510(k) Number: K131848 FDA UDI
FDA Product Code: FRO FDA UDI
GMDN Term: Antimicrobial wound irrigation solution FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1 Liter FDA UDI

Category: Antimicrobial wound irrigation solution

Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container by Urgo Medical North America, LLC — Class U — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Antimicrobial wound irrigation solution.

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Anasept Antimicrobial Skin and Wound cleanser filled in 4 oz. PET bottles with f — ARGENTUM MEDICAL, LLC · U
ELECTROCYN soma — V3Bio Sdn. Bhd · U
Shield Products — Digital Ally, Inc. · U
ExSept Plus — Angelini Pharma Inc. · Class II
BIAKOS™ Antimicrobial Skin & Wound Cleanser — Sanara Medtech Inc. · U
Anasept Antimicrobial Skin and Wound Cleanser — Anacapa Technologies, Inc. · Class II

Cleared under the same submission

K131848 also covers:

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: Urgo Medical North America, LLC

Sources (1)

FDA UDI 36658af0-567e-4066-941a-46b3e3d45d39 38 fields · synced Jun 9, 2026