Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscope suction valve, reusable FDA UDI
- Device Name
- This product is a medical device that is attached to a FUJIFILM gastrointestinal endoscope in order to suck mucus or air in the body cavity. Do not use this product for any other purpose. FDA UDI
- Model / Reference
- SB-605 FDA UDI
- Description
- This product is a medical device that is attached to a FUJIFILM gastrointestinal endoscope in order to suck mucus or air in the body cavity. Do not use this product for any other purpose. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410313314 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 4591abeb-c018-43cb-8bba-55d9722391df 35 fields · synced May 30, 2026