Identity
- Trade Name
- SpeediCath Standard FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Catheter with accessories containing: 1 ready to use coated catheter, 1 pair of gloves, 1 drape, 2 aseptic cleansing wipes, 1 SpeediBag® 700 ml urine bag. FDA UDI
- Model / Reference
- 28482 FDA UDI
- Description
- Catheter with accessories containing: 1 ready to use coated catheter, 1 pair of gloves, 1 drape, 2 aseptic cleansing wipes, 1 SpeediBag® 700 ml urine bag. FDA UDI
Identifiers
- Catalog Number
- 28482 FDA UDI
- Primary DI / UDI-DI
- 05701780209236 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
No
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
Yes
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 UDICatheter Working Length — 35 Centimeter FDA UDICatheter Working Length — 13.9 Inch FDA UDI
Category: Single-administration urethral catheterization kit, single-use
SpeediCath Standard by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Single-administration urethral catheterization kit, single-use.
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- MTG EZ-Gripper® Long — Medical Technologies of Georgia · Class II
- MTG EZ-Advancer® — Medical Technologies of Georgia · Class II
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 ccf73eae-1c8e-4507-a6ab-dbf9af74f953 37 fields · synced May 30, 2026