Identity
- Trade Name
- ComPel Isolation Gown FDA UDI
- Generic Name
- Isolation gown, reusable FDA UDI
- Device Name
- ComPel Isolation Gown, AAMI Level 2, Yellow, 5XL, 100% Polyester, Plastic Snap Closure Neck, Color Coded Neck Binding, Tie Closures Waist, Raglan Sleeves, Poly Cuffs w/Sewn Thumbholes FDA UDI
- Model / Reference
- 661Y3680 FDA UDI
- Description
- ComPel Isolation Gown, AAMI Level 2, Yellow, 5XL, 100% Polyester, Plastic Snap Closure Neck, Color Coded Neck Binding, Tie Closures Waist, Raglan Sleeves, Poly Cuffs w/Sewn Thumbholes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00634916501681 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Isolation gown, reusable
ComPel Isolation Gown by Standard Textile Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
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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
- Standard Textile Co., Inc.
Sources (1)
- FDA UDI 1251334d-b1ad-4eb2-99e6-47e33166cc98 34 fields · synced May 30, 2026