Identity
- Trade Name
- PRIMED FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- PRIMED Gown EUDAMEDAAMI Level 2 Isolation Gown, SMS, Yellow, Thumbloop with Elastic Cuff, Tie Closure, Universal FDA UDI
- Model / Reference
- PM4-57162 EUDAMEDFDA UDI
- Description
- AAMI Level 2 Isolation Gown, SMS, Yellow, Thumbloop with Elastic Cuff, Tie Closure, Universal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391534523338 EUDAMED00842942009570 FDA UDI
- Basic UDI-DI
- 5391534520201PRCAN21LK EUDAMED
- Unit of Use DI
- 05391534523321 EUDAMED
- FDA Product Code
- OEA FDA UDI
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
- GMDN Term
- Isolation gown, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4040 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
Yes
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 11bc8a18-14b5-4ed8-85db-69b382b06436 61 fields · synced May 31, 2026
- FDA UDI 148bb272-ca6a-4c03-afe6-3fdd7d4997a6 34 fields · synced May 30, 2026