Extra LOW Flow GAS Tube
Catalogue number MAJ-1816, listed by Olympus Medical Systems Corp., Japan, under Insufflator, Automatic Carbon-Dioxide For Endoscope. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou | Jiangsu | Repacker / relabeller | 13 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FCX |
| Device type | Insufflator, Automatic Carbon-Dioxide For Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2023-01-16 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, High-level Disinfectant, Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MAJ-1816 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Insufflator, Automatic Carbon-Dioxide For Endoscope | Us Endoscopy | 15 |
| Fujifilm | Fujifilm Corporation | 5 |
| Irrigator/Insufflator | Pentax of America, Inc. | 5 |
| DIN 477 High Pressure Hose for CO2 | Bracco Diagnostics, Inc. | 3 |
| East Coast Surgical Instruments | East Coast Surgical Inc. | 3 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | Richard Wolf Gmbh | 3 |
| CO2MPACT | Us Endoscopy | 3 |
| Endoscopic CO2 Regulation Unit | Olympus Medical Systems Corp. | 3 |
| Protocol Touch Colon Insufflator | Bracco Diagnostics, Inc. | 3 |
| Protocol Accessory Cart | Bracco Diagnostics, Inc. | 2 |
| High Pressure Hose and Yoke | Bracco Diagnostics, Inc. | 2 |
| Cylinder Hose | Olympus Medical Systems Corp. | 2 |
Showing 12 of 38. All products under Insufflator, Automatic Carbon-Dioxide For Endoscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063786 | 2007-03-05 |
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.