Identity
- Trade Name
- SpeediCath Flex Coude FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- Ready to use male catheter. Sterile urinary catheter for intermittent catheterization. FDA UDI
- Model / Reference
- 28920 FDA UDI
- Description
- Ready to use male catheter. Sterile urinary catheter for intermittent catheterization. FDA UDI
Identifiers
- Catalog Number
- 28920 FDA UDI
- Primary DI / UDI-DI
- 05708932643573 FDA UDI
- FDA Product Code
- GBM FDA UDI
- GMDN Term
- Single-administration urethral drainage catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Dimensions & Sizes
- Size
- Catheter Gauge — 10 French FDA UDILength — 44 Centimeter FDA UDIOuter Diameter — 3.3 Millimeter FDA UDILength — 17.32 Inch FDA UDI
SpeediCath Flex Coude by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Coloplast A/S
Sources (1)
- FDA UDI 390b2892-a1e7-417b-9f8d-63b5425aabfd 38 fields · synced May 30, 2026