Simply Saline™ Sterile Saline Solution Wound Wash

FDA UDI

Class U (US FDA UDI)

by Church & Dwight Co., Inc.

Identity

Trade Name: Simply Saline™ Sterile Saline Solution Wound Wash FDA UDI
Generic Name: Wound irrigation sterile saline FDA UDI
Model / Reference: 00022600085522 FDA UDI

Identifiers

Primary DI / UDI-DI: 00022600085522 FDA UDI
510(k) Number: K083355 FDA UDI
FDA Product Code: FRO FDA UDI
GMDN Term: Wound irrigation sterile saline 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

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

Sterilization Method

Radiation Sterilization FDA UDI

Category: Wound irrigation sterile saline

Simply Saline™ Sterile Saline Solution Wound Wash by Church & Dwight Co., Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K083355 also covers:

Simply Saline™ Sterile Saline Solution Wound Wash — Church & Dwight Co., Inc.

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: Church & Dwight Co., Inc.

Sources (1)

FDA UDI a27d224c-0d3e-4dd2-8fa2-041b71fe5010 34 fields · synced Jun 9, 2026