Identity
- Trade Name
- ASP MEDICAL FDA UDI
- Generic Name
- Isolation gown, reusable FDA UDI
- Device Name
- GOWN, POLYETHYLENE BLUE UNIVERSAL SIZE, THUMBHOOK. 1/EA, 15/BG, 75/CS (5BG/CS) FDA UDI
- Model / Reference
- GNT218 FDA UDI
- Description
- GOWN, POLYETHYLENE BLUE UNIVERSAL SIZE, THUMBHOOK. 1/EA, 15/BG, 75/CS (5BG/CS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840216102545 FDA UDI
- FDA Product Code
- LYU 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
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
Category: Isolation gown, reusable
Asp Medical by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Isolation gown, reusable.
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- HENRY SCHEIN — HENRY SCHEIN, INC. · Class II
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
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 8f025d01-7503-4548-aa0d-6637ae046318 33 fields · synced May 30, 2026