Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscope suction valve, reusable FDA UDI
- Device Name
- This device is intended to be installed into the suction valve on the control portion of our ultrasonic endoscope in order to switch suck operation and balloon suck operation selectively. Do not use this product for any other purpose. FDA UDI
- Model / Reference
- SB-601 FDA UDI
- Description
- This device is intended to be installed into the suction valve on the control portion of our ultrasonic endoscope in order to switch suck operation and balloon suck operation selectively. Do not use this product for any other purpose. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410339437 FDA UDI
- FDA Product Code
- FFY FDA UDI
- GMDN Term
- Endoscope suction valve, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope suction valve, reusable
Fujifilm by FUJIFILM Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope suction valve, reusable.
- EM — Allied Medical LLC · Class I
- Suction valve — Olympus Medical Systems Corporation · Class II
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik · Class II
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik · Class II
- SUCTION VALVE — Olympus Medical Systems Corporation · Class II
- SUCTION VALVE — Olympus Medical Systems Corporation · Class II
- PENTAX — HOYA CORPORATION · Class II
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik · 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 I | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (1)
- FDA UDI 72b96413-4763-4b18-81ba-494ce7cf4d1e 35 fields · synced Jun 8, 2026