ComPel Isolation Gown

FDA UDI

Class I (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name: ComPel Isolation Gown FDA UDI
Generic Name: Isolation gown, reusable FDA UDI
Device Name: ComPel Isolation Gown, AAMI Level 2, Yellow, 2XL, 100% Polyester, Tie Closures Neck and Waist, Raglan Sleeves with Poly Cuffs FDA UDI
Model / Reference: 661Y4775 FDA UDI
Description: ComPel Isolation Gown, AAMI Level 2, Yellow, 2XL, 100% Polyester, Tie Closures Neck and Waist, Raglan Sleeves with Poly Cuffs FDA UDI

Identifiers

Primary DI / UDI-DI: 00634916790979 FDA UDI
FDA Product Code: OEA FDA UDI
GMDN Term: Isolation gown, reusable 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Isolation gown, reusable

A comprehensive medical device directory listing the ComPel Isolation Gown, a reusable garment designed to isolate healthcare providers or visitors from patients.

Similar devices

Also classified as Isolation gown, reusable.

Curaplex — BOUND TREE MEDICAL, LLC · Class I
HENRY SCHEIN — HENRY SCHEIN, INC. · Class II
NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
AQUIST WASHABLE ISOLATION GOWN — MAXILL, INC. · Class I
NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
HENRY SCHEIN — HENRY SCHEIN, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Standard Textile Co., Inc.

Sources (1)

FDA UDI db458f04-5fa5-4b45-9631-4635f06248fc 34 fields · synced Jul 21, 2026