Identity
- Trade Name
- Dover FDA UDI
- Generic Name
- Intermittent urethral drainage catheter, non-antimicrobial, reusable FDA UDI
- Device Name
- Red Rubber Urethral Catheter FDA UDI
- Model / Reference
- 8420 FDA UDI
- Description
- Red Rubber Urethral Catheter FDA UDI
Identifiers
- Catalog Number
- 8420 FDA UDI
- Primary DI / UDI-DI
- 10884521019720 FDA UDI
- FDA Product Code
- GBM FDA UDI
- GMDN Term
- Intermittent urethral drainage catheter, non-antimicrobial, reusable 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
Dimensions & Sizes
- Size
- Catheter Gauge — 20 French FDA UDI
Category: Intermittent urethral drainage catheter, non-antimicrobial, reusable
Dover by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, reusable.
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Dover — Cardinal Health 200, LLC · Class II
- AMSure® PVC Intermittent Catheter — AMSINO INTERNATIONAL, INC. · Class II
- Dover — Cardinal Health 200, LLC · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- AMSure® PVC Intermittent Catheter — AMSINO INTERNATIONAL, INC. · 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
- Cardinalhealth
Sources (1)
- FDA UDI ffc5a5be-2903-40e1-80f8-9e20db2133d0 37 fields · synced May 31, 2026