Olympus
13 catalogue numbers from MAJ-1682, listed by Keymed (Medical & Industrial Equipment) Ltd, United Kingdom, under Pump, Air, Non-Manual, For Endoscope. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
13catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Keymed (Medical & Industrial Equipment) Ltd, United Kingdom |
|---|---|
| FDA product code | FEQ |
| Device type | Pump, Air, Non-Manual, For Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-07-05 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: ROOM TEMPERATURE; Storage environment temperature -40 to 70 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MAJ-1682 | 10 | In distribution | |
| MAJ-1681 | 10 | In distribution | |
| MAJ-1608 | 50 | In distribution | |
| MAJ-1651 | 10 | In distribution | |
| MAJ-1607 | 10 | In distribution | |
| OFP-2 (ROW) | In distribution | ||
| MAJ-1608 | 10 | In distribution | |
| MAJ-1606 | 100 | In distribution | |
| MAJ-1607 | 50 | In distribution | |
| OFP-2 (US) | In distribution | ||
| MAJ-1603 | 3 | In distribution | |
| MAJ-1606 | 10 | In distribution | |
| MAJ-1652 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Erbe | Erbe Elektromedizin GmbH | 24 |
| AquaShield | Us Endoscopy | 16 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100899 | 2010-09-13 |
| K000948 | 2000-05-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2024-08-23 | Class II | Equipment maintenance | During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure. | 445 units |
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.