Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Device Name
- TRAY,FOLEY,CATH,SIL-ELAST,18FR,10ML,BG FDA UDI
- Model / Reference
- DYND11008 FDA UDI
- Description
- TRAY,FOLEY,CATH,SIL-ELAST,18FR,10ML,BG FDA UDI
Identifiers
- Catalog Number
- DYND11008 FDA UDI
- Primary DI / UDI-DI
- 10080196991464 FDA UDI
- FDA Product Code
- GBX FDA UDIOHR FDA UDI
- GMDN Term
- Indwelling urethral catheterization kit, adult FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI876.5130 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Indwelling urethral catheterization kit, adult
Medline by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Indwelling urethral catheterization kit, adult.
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- Dover — Cardinal Health 200, LLC · Class II
- Dover — Cardinalhealth · Class II
- NURSE ASSIST — NURSE ASSIST, INC. · Class II
- Bardex® I.C. Foley Catheter Tray — C. R. Bard, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI e75c0bcd-60dc-4551-833d-00bd95e34fd6 36 fields · synced May 31, 2026