Identity
- Trade Name
- Copioumed FDA UDI
- Generic Name
- Surgical/medical face mask, antimicrobial, single-use FDA UDI
- Device Name
- Copioumed The mask is made of melt-blown non-woven fabric for medical personnel to wear during invasive operation, covering the user's mouth, nose and jaw to provide a physical barrier to prevent pathogens, microorganisms, body fluids, particles, etc. FDA UDI
- Model / Reference
- MS032B FDA UDI
- Description
- Copioumed The mask is made of melt-blown non-woven fabric for medical personnel to wear during invasive operation, covering the user's mouth, nose and jaw to provide a physical barrier to prevent pathogens, microorganisms, body fluids, particles, etc. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719882252884 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical face mask, antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class II 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/medical face mask, antimicrobial, single-use
Copioumed by Copious International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CONVERTORS — Cardinal Health 200, LLC · Class II
- CONVERTORS — Cardinal Health 200, LLC · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Copious International Inc.
Sources (1)
- FDA UDI 81cc31a5-530a-4b31-ae5e-51790378e435 34 fields · synced Jun 8, 2026