Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Single-administration urethral drainage/irrigation catheter FDA UDI
- Device Name
- SoftSimplastic 3 Way Foley Couvelaire Tip Catheter FDA UDI
- Model / Reference
- IPN052935 FDA UDI
- Description
- SoftSimplastic 3 Way Foley Couvelaire Tip Catheter FDA UDI
Identifiers
- Catalog Number
- 664176-000240 FDA UDI
- Primary DI / UDI-DI
- 04026704302901 FDA UDI
- FDA Product Code
- EZL FDA UDI
- GMDN Term
- Single-administration urethral drainage/irrigation 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8 Millimeter FDA UDI
Category: Single-administration urethral drainage/irrigation catheter
Rusch by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- NC305000 — NEOCHILD, LLC · Class II
- Halyard — OWENS & MINOR DISTRIBUTION, 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
- Teleflex Incorporated
Sources (1)
- FDA UDI 03dc8376-fedc-4473-88da-d8b0aca7f66a 36 fields · synced Jun 1, 2026