Identity
- Trade Name
- MediChoice FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- Gown Isolation Isolation AAMI Level 3 SMS Full Back Overhead Thumbloop With Elastic Cuff Tie Waist Yellow Universal Not Made With Natural Rubber Latex Medichoice FDA UDI
- Model / Reference
- 55583 FDA UDI
- Description
- Gown Isolation Isolation AAMI Level 3 SMS Full Back Overhead Thumbloop With Elastic Cuff Tie Waist Yellow Universal Not Made With Natural Rubber Latex Medichoice FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30885632138212 FDA UDI
- FDA Product Code
- FYC FDA UDI
- GMDN Term
- Isolation gown, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Isolation gown, single-use
MediChoice by Owens & Minor Distribution, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI 29cd95b6-7134-486d-8fab-39e5866da073 33 fields · synced Jun 8, 2026