Endogator
ENDOGATOR for Pentax Pump
4manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
Record
| Listed by | Medivators Inc, United States |
|---|---|
| FDA product code | FEQ |
| Device type | Pump, Air, Non-Manual, For Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K092429 |
| Record published | 2018-08-16 |
| Record revised | 2022-05-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 50, carton of 10, case of 5, box of 10 |
| Distribution end date | 2022-05-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4005629 | In distribution | |
| 200230B | In distribution | |
| 100130B | In distribution | |
| 200230P | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Erbe | Erbe Elektromedizin GmbH | 24 |
| AquaShield | Us Endoscopy | 16 |
| Olympus | Keymed (Medical & Industrial Equipment) Ltd | 13 |
| Hydra | Boston Scientific Corporation | 13 |
| Erbeflo CleverCap® | Erbe Medical, LLC | 8 |
| Olympus | Olympus Winter & IBE Gmbh | 7 |
| Erbeflo AeroRinse® | Erbe Medical, LLC | 4 |
| Defendo | Medivators Inc | 3 |
| Torrent and AquaShield | Us Endoscopy | 2 |
| CS-05-00-290 OpClear Disposable | Cipher Surgical Ltd | 1 |
| CS-10-00-300 OpClear Disposable | Cipher Surgical Ltd | 1 |
| CS-10-00-315 OpClear Disposable | Cipher Surgical Ltd | 1 |
Showing 12 of 30. All products under Pump, Air, Non-Manual, 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.