Identity
- Trade Name
- PRIMED FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- AAMI Level 3 Procedure Gown, Full Back, Blue, Knit Cuff, Hook & Loop Closure, Universal FDA UDI
- Model / Reference
- PM4-58493 FDA UDI
- Description
- AAMI Level 3 Procedure Gown, Full Back, Blue, Knit Cuff, Hook & Loop Closure, Universal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842942008450 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Isolation gown, single-use
Primed by priMED Medical Products 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
- priMED Medical Products Inc
Sources (1)
- FDA UDI d500ab2d-85a6-4bfb-b6c1-94e16a8d25d2 34 fields · synced May 30, 2026