| Primary Device ID | 14897106954022 |
| NIH Device Record Key | d0a86762-e16a-4355-9210-9ee5f0587e32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | andorate® 3-piece Valve Kit |
| Version Model Number | GAR037 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04897106954025 [Primary] |
| GS1 | 14897106954022 [Package] Contains: 04897106954025 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 24897106954029 [Package] Package: Carton [4 Units] In Commercial Distribution |
| ODC | Endoscope Channel Accessory |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-19 |
| Device Publish Date | 2022-01-11 |
| 14897106953735 | GAR004 |
| 14897106954046 | GAR037P |
| 14897106954022 | GAR037 |
| 14897106953919 | GAR065 |
| 14897106953780 | GAR087 |
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 |