Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscope air/water valve, reusable FDA UDI
- Device Name
- This product is a medical device that is attached to a FUJIFILM ultrasonic endoscope in order to jet air or water as well as to feed water into the balloon. Do not use this product for any other purpose. FDA UDI
- Model / Reference
- AW-601 FDA UDI
- Description
- This product is a medical device that is attached to a FUJIFILM ultrasonic endoscope in order to jet air or water as well as to feed water into the balloon. Do not use this product for any other purpose. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410339420 FDA UDI
- FDA Product Code
- FFY FDA UDI
- GMDN Term
- Endoscope air/water 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 air/water valve, reusable
Fujifilm by FUJIFILM Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- AIR/WATER VALVE FOR CHF-B20 — Olympus Medical Systems Corporation · 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 f733cc79-5905-4666-9c0a-3bf800fa2352 35 fields · synced Jun 1, 2026