Identity
- Trade Name
- UNIBLOCKER FDA UDI
- Generic Name
- Bronchial balloon catheter FDA UDI
- Device Name
- UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right lung in thoracic surgery, lung resection, VATS, lobectomy, etc. FDA UDI
- Model / Reference
- 9.0FR FDA UDI
- Description
- UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right lung in thoracic surgery, lung resection, VATS, lobectomy, etc. FDA UDI
Identifiers
- Catalog Number
- 1203105 FDA UDI
- Primary DI / UDI-DI
- 04544050063715 FDA UDI
- 510(k) Number
- K894337 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Bronchial balloon catheter
Uniblocker by Fuji Systems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bronchial balloon catheter.
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- INSPIRA AIR — ACCLARENT, INC. · Class II
- Elation™ — Merit Medical Systems, Inc. · Class II
- MultiStage® — Dongguan TT Medical, Inc. · Class II
- INSPIRA AIR — ACCLARENT, INC. · Class II
- Blowfish Micro-Infusion Catheter — Mercator MedSystems, Inc. · Class II
- INSPIRA AIR — ACCLARENT, INC. · Class II
Cleared under the same submission
K894337 also covers:
- UNIBLOCKER — Fuji Systems Corp.
- UNIBLOCKER — Fuji Systems Corp.
- UNIBLOCKER — Fuji Systems Corp.
- UNIVENT TUBE (TCB TYPE) — Fuji Systems Corp.
- UNIVENT TUBE (TCB TYPE) — Fuji Systems Corp.
- UNIVENT TUBE (TCB TYPE) — Fuji Systems Corp.
- UNIVENT TUBE (TCB TYPE) — Fuji Systems Corp.
- UNIVENT TUBE (TCB TYPE) — Fuji Systems Corp.
- UNIVENT TUBE (TCB TYPE) — Fuji Systems Corp.
- UNIVENT TUBE (TCB TYPE) — Fuji Systems Corp.
- UNIVENT TUBE (TCB TYPE) — Fuji Systems Corp.
- UNIVENT TUBE (TCB TYPE) — Fuji Systems Corp.
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
- Fuji Systems Corp.
Sources (1)
- FDA UDI caaea298-07ed-4180-b047-a3d69d85e0d8 35 fields · synced May 29, 2026