Identity
- Trade Name
- UPMC FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- GOWN, UPMC ISOLATION AAMI LEVEL 2, XLARGE, YELLOW W/PURPLE LOGO, OVER THE HEAD, THUMBHOOK W/ELASTIC WRIST, FULL BACK, TIE WAIST, 10EA/BG, 10BG/CS (100EA/CS) FDA UDI
- Model / Reference
- UPMCGNA451L2 FDA UDI
- Description
- GOWN, UPMC ISOLATION AAMI LEVEL 2, XLARGE, YELLOW W/PURPLE LOGO, OVER THE HEAD, THUMBHOOK W/ELASTIC WRIST, FULL BACK, TIE WAIST, 10EA/BG, 10BG/CS (100EA/CS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840216100169 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Isolation gown, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Upmc by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Asp Global, LLC
Sources (1)
- FDA UDI b75cd06c-8179-4742-9321-91594bcb7738 34 fields · synced Jun 1, 2026