BioGuard
The single use BioGuard air/water valve is used to control the air/water function of an endoscope during GI endoscopic procedures. The single use BioGuard suction valve is used to control…
The single use BioGuard air/water valve is used to control the air/water function of an endoscope during GI endoscopic procedures. The single use BioGuard suction valve is used to control the suction function of an endoscope during GI endoscopic procedures.
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dalian Create Medical Products Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 2 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Daichuan Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Us Endoscopy, United States |
|---|---|
| FDA product code | FDF |
| Device type | Colonoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K192059 |
| Record published | 2016-09-17 |
| Record revised | 2020-03-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 25 °C |
| Packaging | Box of 50, case of 50 |
| Distribution end date | 2026-01-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00711780 | Withdrawn | |
| 00711780 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fuse | Endochoice, Inc. | 52 |
| Colonoscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 51 |
| Fujifilm | Fujifilm Corporation | 40 |
| Pentax | Hoya Corporation | 37 |
| Video Colonoscope | Pentax of America, Inc. | 25 |
| G-EYE Colonoscope | Smart Medical Systems Ltd. | 24 |
| Medisono | Medisono, LLC | 18 |
| Evis Exera lll Colonovideoscope | Olympus Medical Systems Corp. | 16 |
| Endoch | Endoch Inc | 14 |
| Evis Exera II Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonoscope And Accessories, Flexible/Rigid | Hangzhou AGS MedTech Co., Ltd. | 10 |
Showing 12 of 115. All products under Colonoscope And Accessories, Flexible/Rigid
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.