Hygea Sterile Saline Wipe

FDA UDI

Class I (US FDA UDI)

by Professional Disposables International, Inc.

Identity

Trade Name: Hygea Sterile Saline Wipe FDA UDI
Generic Name: Skin-cleaning wipe, sterile FDA UDI
Device Name: Wipe used for cleansing with a sterile saline solution where indicated FDA UDI
Model / Reference: C22370 FDA UDI
Description: Wipe used for cleansing with a sterile saline solution where indicated FDA UDI

Identifiers

Catalog Number: C22370 FDA UDI
Primary DI / UDI-DI: 00310819000307 FDA UDI
FDA Product Code: FRL FDA UDI
GMDN Term: Skin-cleaning wipe, sterile FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5300 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 6 Inch FDA UDI
Width — 4 Inch FDA UDI

Category: Skin-cleaning wipe, sterile

Hygea Sterile Saline Wipe by Professional Disposables International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Professional Disposables International, Inc.

Sources (1)

FDA UDI 0ac5923d-85d4-4377-98c1-a982364f18b7 36 fields · synced Jun 8, 2026