Erbe
Hybrid OFP & EndoStat Tubing/ Cap Set for Olympus® Scope
10manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (3), Chongqing (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou | Jiangsu | Repacker / relabeller | 13 |
| Chongqing Jinshan Science & Technology (Group) Co., Ltd. | Chongqing | Chongqing | Manufacturer | 4 |
Record
| Listed by | Erbe Elektromedizin GmbH, Germany |
|---|---|
| FDA product code | OCX |
| Device type | Endoscopic Irrigation/Suction System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K182444 |
| Record published | 2019-01-09 |
| Record revised | 2021-12-14 (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 |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from heat and direct sunlight |
| Packaging | Level: 1 of 10, level: 2 of 5, level: 1 of 7, level: 2 of 3, level 1 of 7, level 2 of 35 |
| Sizes | Length 0.1 to 3.5 m; length 50 to 70 mm |
| Distribution end date | 2023-10-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20325-322 | Length 2.900 m | In distribution |
| 20325-324 | Length 2.900 m | In distribution |
| 20325-323 | Length 2.900 m | In distribution |
| 20325-225 | Withdrawn | |
| 20325-213 | Length 0.100 m | Withdrawn |
| 20325-203 | Length 3.5 m | Withdrawn |
| 20325-202 | Length 3.500 m | Withdrawn |
| 20325-215 | Length 70.000 mm | Withdrawn |
| 20325-218 | Length 70.000 mm | Withdrawn |
| 20325-217 | Length 50.000 mm | Withdrawn |
| 20325-222 | Length 2.900 m | Withdrawn |
| 20325-211 | Length 50.000 mm | Withdrawn |
| 20325-248 | Length 3.5 m | Withdrawn |
| 20325-212 | Length 70.000 mm | Withdrawn |
| 20325-224 | Length 2.900 m | Withdrawn |
| 20325-215 | Length 70.000 mm | Withdrawn |
| 20325-223 | Length 2.900 m | Withdrawn |
| 20325-216 | Length 0.100 m | Withdrawn |
| 20325-205 | Length 3.500 m | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endogator Kit | Medivators Inc | 37 |
| Clean Connecting Tube | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 21 |
| Endogator | Medivators Inc | 18 |
| Torrent | Us Endoscopy | 14 |
| ClearCap Distal Attachment | Finemedix | 14 |
| EndoGator Hybrid | Medivators Inc | 13 |
| Endoscopic Irrigation/Suction System | Pentax of America, Inc. | 12 |
| Reveal | Us Endoscopy | 12 |
| Endogator hybrid irrigation tubing | Medivators Inc | 10 |
| Erbeflo® 2 | Erbe Medical, LLC | 9 |
| BullDog® | Diversatek Healthcare Inc | 9 |
| Olympus | Keymed (Medical & Industrial Equipment) Ltd | 8 |
Showing 12 of 123. All products under Endoscopic Irrigation/Suction System
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.