Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Bronchial balloon catheter FDA UDI
- Device Name
- Bronchus blocker set FDA UDI
- Model / Reference
- IPN044219 FDA UDI
- Description
- Bronchus blocker set FDA UDI
Identifiers
- Catalog Number
- 330602-000060 FDA UDI
- Primary DI / UDI-DI
- 04026704095490 FDA UDI
- 510(k) Number
- K010596 FDA UDI
- FDA Product Code
- CBI FDA UDI
- GMDN Term
- Bronchial balloon catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5740 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 6 French FDA UDI
Category: Bronchial balloon catheter
Rusch by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bronchial balloon catheter.
- MultiStage® — Dongguan TT Medical, Inc. · Class II
- Elation™ — Merit Medical Systems, Inc. · Class II
- INSPIRA AIR — ACCLARENT, INC. · Class II
- Elation™ — Merit Medical Systems, Inc. · Class II
- MultiStage® — Dongguan TT Medical, Inc. · Class II
- UNIBLOCKER — Fuji Systems Corp. · Class II
- INSPIRA AIR — ACCLARENT, INC. · Class II
- Blowfish Micro-Infusion Catheter — Mercator MedSystems, Inc. · Class II
Cleared under the same submission
K010596 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 298f91ce-5c89-4c01-bb05-4e8cd91e9cfa 37 fields · synced May 30, 2026