Identity
- Trade Name
- Copioumed FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling and administration. This device is non-sterile and for single use only. FDA UDI
- Model / Reference
- CTN3B102-1 FDA UDI
- Description
- Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling and administration. This device is non-sterile and for single use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719882251412 FDA UDI
- 510(k) Number
- K230135 FDA UDI
- FDA Product Code
- FYC FDA UDIQSO 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
No
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 Copioumed International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230135 also covers:
- Copioumed — COPIOUMED INTERNATIONAL INC.
- Copioumed — COPIOUMED INTERNATIONAL INC.
- Copioumed — COPIOUMED INTERNATIONAL INC.
- Copioumed — COPIOUMED INTERNATIONAL INC.
- Copioumed — COPIOUMED INTERNATIONAL INC.
- Copioumed — COPIOUMED INTERNATIONAL INC.
- Copioumed — COPIOUMED INTERNATIONAL INC.
- Copioumed — COPIOUMED INTERNATIONAL INC.
- Copioumed — COPIOUMED INTERNATIONAL INC.
- Copioumed — COPIOUMED INTERNATIONAL INC.
- Copioumed — COPIOUMED INTERNATIONAL INC.
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
- Copioumed International Inc.
Sources (1)
- FDA UDI 411db3e4-de37-4eb3-b7c5-ee98adad8e97 35 fields · synced Jun 8, 2026