Bardex® Lubricath® Foley Catheter Ovoid Fluted Balloon
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Bardex® Lubricath® Foley Catheter Ovoid Fluted Balloon FDA UDI
- Generic Name
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
- Device Name
- Bardex® Lubricath® Foley Catheter 75cc Ovoid Fluted Balloon Lubricious Coated FDA UDI
- Model / Reference
- 0113L24 FDA UDI
- Description
- Bardex® Lubricath® Foley Catheter 75cc Ovoid Fluted Balloon Lubricious Coated FDA UDI
Identifiers
- Catalog Number
- 0113L24 FDA UDI
- Primary DI / UDI-DI
- 00801741018077 FDA UDI
- FDA Product Code
- EZC FDA UDI
- GMDN Term
- Indwelling urethral drainage balloon catheter, non-antimicrobial 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
Single Use
Yes
Implantable
No
Contains Latex
Yes
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Catheter Gauge — 24 French FDA UDI
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
The Bardex Lubricath Foley Catheter Ovoid Fluted Balloon is a single-use, in-dwell indwelling urethral drainage balloon catheter designed for urinary drainage and infusion of fluids. It features an inflatable balloon at its distal tip, which can be bent to facilitate insertion into the urinary bladder or prostatic bed.
Similar devices
Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
- Sunmed — SunMed · Class II
- Dover — Cardinalhealth · Class II
- Silicone Foley Catheters — Dynarex Corp. · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- Porges Coloplast — Coloplast A/S · Class II
- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
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
- C. R. Bard, Inc.
Sources (1)
- FDA UDI 136274d8-7568-484b-9f7d-12bbaf1eb044 36 fields · synced Jul 24, 2026