Identity
- Trade Name
- MediChoice FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- Gown Isolation Aami Level 3 Sms Full Back Overhead Thumbloop With Elastic Cuff Tie Waist Blue Universal Not Made With Natural Rubber Latex MediChoice FDA UDI
- Model / Reference
- 55883 FDA UDI
- Description
- Gown Isolation Aami Level 3 Sms Full Back Overhead Thumbloop With Elastic Cuff Tie Waist Blue Universal Not Made With Natural Rubber Latex MediChoice FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30885632138236 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
The MediChoice isolation gown is a high-quality, single-use medical device designed to provide optimal protection for healthcare professionals and visitors from airborne pathogens. Engineered with safety in mind, this gown meets the highest standards of sterilization and meets regulatory requirements.
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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 7e930864-28d8-4735-9f9b-a8e4dec73c92 33 fields · synced Jul 8, 2026