| Primary Device ID | 00827002214811 |
| NIH Device Record Key | e513268f-3db9-4288-af64-04d4306e3405 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leung |
| Version Model Number | G21481 |
| Catalog Number | ENBD-6.5-LEUNG-7-C |
| Company DUNS | 988559035 |
| Company Name | COOK IRELAND LTD |
| 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 | true |
| 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 |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location, away from temperature extremes |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002214811 [Primary] |
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-24 |
| 00827002215238 | Leung, Nasal Biliary Drainage Set |
| 00827002215207 | Leung, Nasal Biliary Drainage Set |
| 00827002221482 | Leung, Nasal Biliary Drainage Catheter |
| 00827002214811 | Leung, Nasal Biliary Drainage Catheter |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LEUNG 98008745 not registered Live/Pending |
Xiangyang Nianhuajingyingjianzhuzhuangshi Co., Ltd 2023-05-23 |
![]() LEUNG 90835130 not registered Live/Pending |
Dongguanzhenghe Daily Products Co, Ltd. 2021-07-19 |
![]() LEUNG 88062263 not registered Live/Pending |
Dongguan Zhenghe Daily Products Co., Ltd. 2018-08-02 |