Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscope leak tester tubing FDA UDI
- Device Name
- This product is intended to check whether the FUJIFILM Leak Tester LT-100 can properly test the airtightness of a FUJIFILM endoscope. Do not use this product for any other purposes. FDA UDI
- Model / Reference
- CT-2LT FDA UDI
- Description
- This product is intended to check whether the FUJIFILM Leak Tester LT-100 can properly test the airtightness of a FUJIFILM endoscope. Do not use this product for any other purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410520910 FDA UDI
- FDA Product Code
- FCY FDA UDI
- GMDN Term
- Endoscope leak tester tubing 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 leak tester tubing
Fujifilm by FUJIFILM Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope leak tester tubing.
- ALT-Pro LEAK TEST AIR TUBE — Olympus Medical Systems Corporation · Class II
- PENTAX Medical — HOYA CORPORATION · Class II
- FUJIFILM — FUJIFILM Corporation · Class I
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 67a67769-9028-4be0-9550-0fb3ee3314b2 34 fields · synced May 30, 2026