Identity
- Trade Name
- PRIMED FDA UDI
- Generic Name
- Professional examination gown, single-use FDA UDI
- Device Name
- PRIMED Gown EUDAMEDOverhead Cover Gown / Thumbloop with Elastic Cuff / Open Back / Universal / Yellow FDA UDI
- Model / Reference
- PM4-67364 EUDAMEDFDA UDI
- Description
- Overhead Cover Gown / Thumbloop with Elastic Cuff / Open Back / Universal / Yellow FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391534523758 EUDAMED00842942013928 FDA UDI
- Basic UDI-DI
- 5391534520201PRCAN21LK EUDAMED
- Unit of Use DI
- 05391534523741 EUDAMED
- FDA Product Code
- FME FDA UDI
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
- GMDN Term
- Professional examination gown, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6265 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PRIMED Gown by Primed Medical Products Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5391534520201PRCAN21LK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PRIMED Medical Products Inc.
- EUDAMED SRN
- CA-MF-000014307
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 433d3abd-a98d-4de2-a85b-744ddcb84ddc 61 fields · synced Jul 23, 2026
- FDA UDI 8e9b85fc-e6f5-4bcb-bd55-bca9a3bb2b6b 34 fields · synced May 30, 2026