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, breathable, avoid dust and liquid penetration. It can cover the body and all clothing, forming a physical barrier to prevent the spread of substances such as microorganisms. In order to protect the safety of medical staff and avoid the secondary infection of patients. FDA UDI
- Model / Reference
- IGN0G2060-1 FDA UDI
- Description
- Copioumed Isolation gown is made of non-woven fabric, breathable, avoid dust and liquid penetration. It can cover the body and all clothing, forming a physical barrier to prevent the spread of substances such as microorganisms. In order to protect the safety of medical staff and avoid the secondary infection of patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719882253287 FDA UDI
- FDA Product Code
- FYC FDA UDI
- GMDN Term
- Isolation gown, 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: Isolation gown, single-use
Copioumed by Copious International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Isolation gown, single-use.
- VIVIT Supply — Vivit Supply LLC · Class I
- customized — Qingdao Bestex Rubber & Plastic Products Co., Ltd. · Class I
- CONVERTORS — Cardinal Health 200, LLC · Class I
- Industrial Gown - White — ULINE, INC. · Class I
- Protexter — ICP MEDICAL, LLC · Class I
- 3D DENTAL-ESSENTIALS — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- VIVIT Supply — Vivit Supply LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Copious International Inc.
Sources (1)
- FDA UDI 844b5dc4-7012-4a56-9e9b-22afb1e8acb1 34 fields · synced May 30, 2026