Identity
- Trade Name
- Resilient Medical Solutions FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- AAMI 1 Fullback Gown, Over-the-Head, Thumbloop Elastic Cuff, Yellow, Universal FDA UDI
- Model / Reference
- RMAM1YU FDA UDI
- Description
- AAMI 1 Fullback Gown, Over-the-Head, Thumbloop Elastic Cuff, Yellow, Universal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850061262912 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
- 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
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, single-use
Resilient Medical Solutions by Resilient Medical Solutions, LLC — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Resilient Medical Solutions, LLC
Sources (1)
- FDA UDI 14afd1e5-d0ee-4afb-8a71-6fc37f485e54 33 fields · synced Jun 6, 2026