AquaShield
The AquaShield system CO2 – Pentax is intended to be used with an air or carbon dioxide (CO2) source from an endoscope with the purpose of supplying sterile water to the endoscope during…
The AquaShield system CO2 → Pentax is intended to be used with an air or carbon dioxide (CO2) source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures.
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 | Us Endoscopy, United States |
|---|---|
| FDA product code | FEQ |
| Device type | Pump, Air, Non-Manual, For Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Record published | 2020-04-01 |
| Record revised | 2023-09-11 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Dry |
| Packaging | Box of 25, case of 25 |
| Distribution end date | 2023-11-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00711551 | Withdrawn | |
| 00711541 | Withdrawn | |
| 00711543 | Withdrawn | |
| 00711542 | Withdrawn | |
| 711551 | Withdrawn | |
| 00711553 | Withdrawn | |
| 00711549 | Withdrawn | |
| 00711542 | Withdrawn | |
| 00711549 | Withdrawn | |
| 00711553 | Withdrawn | |
| 00711541 | Withdrawn | |
| 00711540 | Withdrawn | |
| 00711543 | Withdrawn | |
| 00711550 | Withdrawn | |
| 00711540 | Withdrawn | |
| 711550 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Erbe | Erbe Elektromedizin GmbH | 24 |
| 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 |
| Endogator | Medivators Inc | 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.