Andorate® Single Chamber Polyp Trap
Catalogue number GAR014, listed by GA Health Company Limited, Hong Kong, under Bottle, Collection And Trap, Breathing System (Uncalibrated). 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Yuyao Jiahua Medical Appliance, Co., Ltd. | Yuyao | Zhejiang | Manufacturer | 5 |
Record
| Listed by | GA Health Company Limited, Hong Kong |
|---|---|
| FDA product code | CBC |
| Device type | Bottle, Collection And Trap, Breathing System (Uncalibrated) |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-17 |
| Record revised | 2022-11-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 50, carton of 6 |
| Distribution end date | 2021-04-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GAR014 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CeroFrict | SML MED-Tech Solutions Limited | 13 |
| andorate® Four Chamber Polyp Trap | GA Health Company Limited | 3 |
| andorate® Click4Catch™ Click into Place Polyp Trap with Four Removable Capture C | GA Health Company Limited | 2 |
| andorate® Pearlcatch™ Single Chamber Polyp Trap | GA Health Company Limited | 2 |
| andorate® ThomasTrap™ Polyp Trap with Two Removable Chambers | GA Health Company Limited | 2 |
| Single Chamber Polyp Trap | GA Health Company Limited | 1 |
| Polyp Trap with Two Removable Chambers (Non-sterile) | GA Health Company Limited | 1 |
| aScope BronchoSampler™Specimen Sampling System – Single Use | Ambu A/S | 1 |
| Jedmed | Jedmed Instrument Company | 1 |
| Four Chamber Polyp Trap | GA Health Company Limited | 1 |
| Single Chamber Polyp Trap (Non-sterile) | GA Health Company Limited | 1 |
| Capture | Diversatek Healthcare Inc | 1 |
Showing 12 of 17. All products under Bottle, Collection And Trap, Breathing System (Uncalibrated)
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.