Identity
- Trade Name
- Self-Cath Closed System FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Self-Cath Closed System Kit. Straight Tip. Female. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 14, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only. FDA UDI
- Model / Reference
- 50293 FDA UDI
- Description
- Self-Cath Closed System Kit. Straight Tip. Female. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 14, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only. FDA UDI
Identifiers
- Catalog Number
- 50293 FDA UDI
- Primary DI / UDI-DI
- 05708932279666 FDA UDI
- FDA Product Code
- FCM 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
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 — 14 French FDA UDICatheter Working Length — 5.2 Inch FDA UDICatheter Working Length — 13 Centimeter FDA UDI
Category: Single-administration urethral catheterization kit, single-use
Self-Cath Closed System by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Single-administration urethral catheterization kit, single-use.
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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 3af938fe-d5f2-4f63-9f0e-9463f1cd431c 37 fields · synced May 30, 2026