Zutron
Zutron Auto Leak Tester Power Supply
4manufacturers in China registered for this device type
6catalogue numbers in this listing
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 | Pentax of America, Inc., United States |
|---|---|
| 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 |
| 510(k) | K093718 |
| Record published | 2018-03-15 |
| Record revised | 2021-08-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZUTR10002P | In distribution | |
| ZUTR10003P | In distribution | |
| ZUTR10001PA | In distribution | |
| ZUTR10003WMP | In distribution | |
| ZUTRT1079P5PND | In distribution | |
| ZUTR10003TG | 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 |
| Fujifilm | Fujifilm Corporation | 3 |
| 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.