Identity
- Trade Name
- Copioumed FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- COPIOUMED Isolation gown is made of non-woven fabric, it can cover the body of all clothing, forming a physical barrier to prevent the spread of substances such as microorganisms. It has permeability resistance, wear resistance and tear resistance. To protect the safety of medical staff and avoid the secondary infection of patients. FDA UDI
- Model / Reference
- IGN1B6073-1 FDA UDI
- Description
- COPIOUMED Isolation gown is made of non-woven fabric, it can cover the body of all clothing, forming a physical barrier to prevent the spread of substances such as microorganisms. It has permeability resistance, wear resistance and tear resistance. To protect the safety of medical staff and avoid the secondary infection of patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719882253447 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Isolation gown, single-use
Copioumed by Copious International Inc. — 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
- Copious International Inc.
Sources (1)
- FDA UDI 76672009-76f8-495d-b188-842dcd03b317 34 fields · synced May 30, 2026