Fujifilm
Fujifilm’s endoscope leak tester pressurizes the inside of an endoscope so its airtightness can be checked. It is an accessory used to identify leakage in the scope before the instrument…
Fujifilm’s endoscope leak tester pressurizes the inside of an endoscope so its airtightness can be checked. It is an accessory used to identify leakage in the scope before the instrument proceeds through its reprocessing workflow.
The tester supplies air to the endoscope interior. A leak allows that air to escape, and the prescribed inspection process is used to identify the loss of airtightness. The appropriate test method depends on the endoscope and tester combination.
Listed Item
This product is a leak tester for the purpose of pressurizing the inside of the endoscope and confirming that there is no airtight leakage of the endoscope in medical facilities. Do not use for any other purpose.
Pressure Check
A loss of airtightness indicates a break in the endoscope’s sealed interior. Leak testing provides a check on that enclosure before subsequent cleaning and disinfection, using the procedure specified for the scope and tester.
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
| MDF Instruments Medifriend Inc. | Song Jiang District | Shanghai | Repacker / relabeller | 13 |
| Yangjiang Kaimi Import Export Co., Ltd. | Yangjiang | Guangdong | Manufacturer | 7 |
Record
| Listed by | Fujifilm Corporation, Japan |
|---|---|
| FDA product code | FCY |
| Device type | Bulb, Inflation, For Endoscope |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-12-15 |
| Record revised | 2025-10-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CT-1LT | In distribution | |
| LT-100 | In distribution | |
| CT-2LT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bulb, Inflation, For Endoscope | Medivators Inc | 15 |
| Zutron Medical | Zutron Medical, L.L.C. | 12 |
| Bulb, Inflation, For Endoscope | Karl Storz GmbH & Co. KG | 6 |
| Zutron | Pentax of America, Inc. | 6 |
| Disposable Bulb & Bladder | Healthmark Industries Co., Inc. | 2 |
| Merit Medical® | Merit Medical Systems, Inc. | 2 |
| AutoSink with Endoscope Leak Tester | Torvan Medical Inc. | 2 |
| AutoSink Adapter, Olympus Colonoscope, Gastroscope with Aux Water Channel | Torvan Medical Inc. | 2 |
| Sterile Bulb & Bladder | Healthmark Industries Co., Inc. | 1 |
| AutoSink Adapter, Pentax Dual Channel Colonoscope | Torvan Medical Inc. | 1 |
| FLY | Shanghai FLY Medical Devices Co., Ltd. | 1 |
| AutoSink Adapter, Olympus Duodenal Scope with Washing Ercp | Torvan Medical Inc. | 1 |
Showing 12 of 32. All products under Bulb, Inflation, For Endoscope
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.