Identity
- Trade Name
- SpeediCath Compact Set FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Ready to use coated catheter. Nelaton. For males only . Length: 11.8 in, Vol 750 ml. Inner catheter CH/FR 12/4.0 mm. Outer catheter CH/FR 18/6.0 mm. Rx only. FDA UDI
- Model / Reference
- 28422 FDA UDI
- Description
- SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Ready to use coated catheter. Nelaton. For males only . Length: 11.8 in, Vol 750 ml. Inner catheter CH/FR 12/4.0 mm. Outer catheter CH/FR 18/6.0 mm. Rx only. FDA UDI
Identifiers
- Catalog Number
- 28422 FDA UDI
- Primary DI / UDI-DI
- 05708932967150 FDA UDI
- FDA Product Code
- GBM FDA UDI
- GMDN Term
- Single-administration urethral catheterization kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- 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 — 12 French FDA UDICatheter Working Length — 11.8 Inch FDA UDICatheter Working Length — 30 Centimeter FDA UDI
Category: Single-administration urethral catheterization kit, single-use
SpeediCath Compact Set by Coloplast A/S — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI 507aa8fe-19a6-4d16-b4fb-96e3445ddfbf 37 fields · synced May 30, 2026