Erbeflo AeroRinse®
CO2 and Water Tubing/Cap Set for Olympus® Scopes & UCR
4manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall
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 | Erbe Medical, LLC, United States |
|---|---|
| FDA product code | FEQ |
| Device type | Pump, Air, Non-Manual, For Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K162152 |
| Record published | 2023-09-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from heat and direct sunlight; Special storage condition: Keep dry |
| Packaging | Level 1 of 10, level 2 of 5 |
| Sizes | Length 0.4 m |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20325-236 | Length 0.4 m | In distribution |
| 20325-235 | Length 0.4 m | In distribution |
| 20325-243 | Length 0.4 m | In distribution |
| 20325-237 | Length 0.4 m | In distribution |
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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Erbe Medical, LLC | 510(k) number | 2026-03-31 | Class II | Component change control | Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector u | 260,962 |
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.