Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container

FDA UDI

Class U (US FDA UDI)

by Urgo Medical North America, LLC

Identity

Trade Name: Vashe Wound Solution 250 ml (8.5 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 250 ml (8.5 fl oz)) size with an instillation cap. FDA UDI
Model / Reference: 00316 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 250 ml (8.5 fl oz)) size with an instillation cap. FDA UDI

Identifiers

Catalog Number: 00316 FDA UDI
Primary DI / UDI-DI: 00851383003160 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 — 250 Milliliter FDA UDI

Category: Antimicrobial wound irrigation solution

Vashe Wound Solution 250 ml (8.5 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 94de0463-c29a-4f53-b47c-dbdd7710e7f7 38 fields · synced Jun 9, 2026