| Primary Device ID | 14897106950369 |
| NIH Device Record Key | e3cf0cf9-1b34-45e7-af56-a572156ee94d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | andorate® Disposable Endoscope Valves Set |
| Version Model Number | GAR081P |
| Company DUNS | 686908512 |
| Company Name | GA Health Company Limited |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04897106950362 [Primary] |
| GS1 | 14897106950369 [Package] Contains: 04897106950362 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 24897106950366 [Package] Package: Carton [4 Units] In Commercial Distribution |
| OCX | Endoscopic Irrigation/Suction System |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-03-02 |
| Device Publish Date | 2020-05-28 |
| 14897106950307 | GAR037 |
| 14897106952592 | GAR066 |
| 14897106952196 | GAR065 |
| 14897106950321 | GAR037C |
| 14897106950239 | GAR004C |
| 14897106950222 | GAR004 |
| 14897106950314 | GAR037P |
| 14897106950369 | GAR081P |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ANDORATE 97445913 not registered Live/Pending |
GA HEALTH COMPANY LIMITED 2022-06-07 |
![]() ANDORATE 97445874 not registered Live/Pending |
GA HEALTH COMPANY LIMITED 2022-06-07 |
![]() ANDORATE 87709057 5589076 Live/Registered |
GA HEALTH COMPANY LIMITED 2017-12-05 |