Identity
- Trade Name
- Coflex FDA UDI
- Generic Name
- Pressure bandage, Hevea-latex, single-use FDA UDI
- Device Name
- COFLEX Self Adhering Compression Bandage, TAN 2"X5Yds FDA UDI
- Model / Reference
- TAN 2"X5Yds FDA UDI
- Description
- COFLEX Self Adhering Compression Bandage, TAN 2"X5Yds FDA UDI
Identifiers
- Catalog Number
- 3200TN-036 FDA UDI
- Primary DI / UDI-DI
- 10724004321073 FDA UDI
- FDA Product Code
- FQM FDA UDI
- GMDN Term
- Pressure bandage, Hevea-latex, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 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
Yes
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: Pressure bandage, Hevea-latex, single-use
Coflex by Andover Healthcare 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
- Andover Healthcare Inc.
Sources (1)
- FDA UDI 130a7069-928b-40e5-8423-ecaf9c8914c3 34 fields · synced May 30, 2026