Primary Device ID | 14897106955579 |
NIH Device Record Key | aad2c451-c26c-49ef-b367-90b40ba1f814 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | andorate® Champion 3-piece valve kit |
Version Model Number | 101004 |
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 | 04897106955572 [Primary] |
GS1 | 14897106955579 [Package] Contains: 04897106955572 Package: Box [50 Units] In Commercial Distribution |
GS1 | 24897106955576 [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 | 2024-10-14 |
Device Publish Date | 2024-10-04 |
14897106955616 | 101037 |
14897106955579 | 101004 |
14897106955531 | 101065 |
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 |