Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- CATHETER,URETHRAL,REDRUBBER,COUDE,16FR FDA UDI
- Model / Reference
- DYND13616 FDA UDI
- Description
- CATHETER,URETHRAL,REDRUBBER,COUDE,16FR FDA UDI
Identifiers
- Catalog Number
- DYND13616 FDA UDI
- Primary DI / UDI-DI
- 10888277720879 FDA UDI
- FDA Product Code
- EYB 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Category: Single-administration urethral drainage catheter
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Single-administration urethral drainage catheter.
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- Magic3™ Intermittent Catheter — C. R. Bard, Inc. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- CURE ULTRA MALE CATHETER — CONVATEC, PURCHASING DEPARTMENT · 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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 71af8b2e-05e7-4d75-85ef-9b81ff6311c2 35 fields · synced Jun 8, 2026