Identity
- Trade Name
- PRIMED FDA UDI
- Generic Name
- Professional examination gown, single-use FDA UDI
- Device Name
- PRIMED Gown EUDAMEDFluid Resistant Isolation Gown, Yellow, Polyethylene-Coated Psb, Full Back, Tie Closure, And Knit Cuff FDA UDI
- Model / Reference
- PM4-67194 EUDAMEDFDA UDI
- Description
- Fluid Resistant Isolation Gown, Yellow, Polyethylene-Coated Psb, Full Back, Tie Closure, And Knit Cuff FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391534523666 EUDAMED00842942007828 FDA UDI
- Basic UDI-DI
- 5391534520201PRCAN21LK EUDAMED
- Unit of Use DI
- 05391534523659 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 3059aba6-cc97-47d3-a483-eb9a2ab6e42f 61 fields · synced Jul 22, 2026
- FDA UDI 8b04cb40-1c4f-4c95-a43b-662b16e36fcc 34 fields · synced May 30, 2026