| Primary Device ID | 04712688051460 |
| NIH Device Record Key | 7af63fe1-1059-42d3-970a-60843f399eee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hsiner |
| Version Model Number | 1 |
| Catalog Number | 10243 |
| Company DUNS | 657310868 |
| Company Name | HSINER CO., 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04712688051460 [Primary] |
| BZD | Ventilator, Non-Continuous (Respirator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-06-29 |
| 04712688051460 | COMFO CPAP Silicone Face mask set, size: S |
| 14712688057445 | HMEF REF70531 |
| 14712680057436 | B/V Filter REF 70530 |
| 14712688052976 | Pleated HME REF70544 |
| 04712688051286 | NIPPV Silicone Face mask set |
| 04711064681680 | High flow nasal cannula, L |
| 04711064681673 | High flow nasal cannula, M |
| 04711064681666 | High flow nasal cannula, S |
| 04711064681659 | High Flow Nasal Cannula XS |
| 04711064686791 | Catheter Mount W/ collapsible tubing 18cm,22OD/15ID, 22ID |
| 04711064686784 | Corrugate Catheter Mount 18cm, 22OD/15ID; 22IDw/sampling port |
| 04711064686777 | Collapsible Catheter Mount, tubing length: 15cm, 22OD/15D,22ID, w/sampling port |
| 04711064686760 | Corrugate Catheter Mount, tubing length: 15cm, 22OD/15ID; 22ID |
| 04711064686753 | Corrugate Catheter Mount tubing length: 15cm, 22OD/15ID; 22ID |