Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Device Name
- CATHETER,FOLEY,100%SILICONE,24FR,30ML,LF FDA UDI
- Model / Reference
- DYND11536 FDA UDI
- Description
- CATHETER,FOLEY,100%SILICONE,24FR,30ML,LF FDA UDI
Identifiers
- Catalog Number
- DYND11536 FDA UDI
- Primary DI / UDI-DI
- 10080196029532 FDA UDI
- 510(k) Number
- K082815 FDA UDI
- FDA Product Code
- EZL FDA UDI
- GMDN Term
- Indwelling urethral catheterization kit, adult 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
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: Indwelling urethral catheterization kit, adult
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indwelling urethral catheterization kit, adult.
- Bard® Drain Bag Foley Tray with Bardex® All-Silicone Catheter — C. R. Bard, Inc. · Class II
- Dover — Cardinalhealth · Class II
- Dover — Cardinalhealth · Class II
- Dover — Cardinal Health 200, LLC · Class II
- 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
Cleared under the same submission
K082815 also covers:
- AMSure® 100% Silicone Foley Catheter — AMSINO INTERNATIONAL, INC.
- AMSure® 100% Silicone Foley Catheter — AMSINO INTERNATIONAL, INC.
- AMSure® Silicone Coated Latex Foley Catheter — AMSINO INTERNATIONAL, INC.
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Foley Catheter — GERI-GENTLE CORPORATION
- Foley Catheter — GERI-GENTLE CORPORATION
- Foley Catheter — GERI-GENTLE CORPORATION
- Foley Catheter — GERI-GENTLE CORPORATION
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
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 3a123de0-4d3b-4317-8fab-aa8b0bd97264 37 fields · synced Jun 8, 2026