| Primary Device ID | 14897106954985 |
| NIH Device Record Key | 2048af58-5f9b-465b-b95d-af5ecdad3247 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | andorate® Irrigation Tubing |
| Version Model Number | GAR073 |
| 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 | false |
| 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 | 04897106954988 [Primary] |
| GS1 | 14897106954985 [Package] Contains: 04897106954988 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 24897106954982 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-07 |
| Device Publish Date | 2022-01-28 |
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 |