A Plus

FDA UDI

Class I (US FDA UDI)

by A Plus International, Inc

Identity

Trade Name: A Plus FDA UDI
Generic Name: Patient gown, single-use FDA UDI
Device Name: COVERALL, SMS, H/B, ZIP;ELAS, WHT, XL, 25/CS FDA UDI
Model / Reference: 1 FDA UDI
Description: COVERALL, SMS, H/B, ZIP;ELAS, WHT, XL, 25/CS FDA UDI

Identifiers

Catalog Number: 68-623W-X FDA UDI
Primary DI / UDI-DI: 00683534080283 FDA UDI
FDA Product Code: LYU FDA UDI
GMDN Term: Patient gown, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Category: Patient gown, single-use

A Plus by A Plus 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: A Plus International, Inc

Sources (1)

FDA UDI c08a7759-d847-4c7b-96a0-0ad1c44380cf 34 fields · synced May 30, 2026