| Primary Device ID | 16938119331115 |
| NIH Device Record Key | 438edba6-3812-480d-846a-20cdd5932690 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | Tracheotomy |
| Company DUNS | 526982680 |
| Company Name | Henan Tuoren Medical Device Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06938119331101 [Primary] |
| GS1 | 16938119331115 [Package] Contains: 06938119331101 Package: Middle Box [200 Units] In Commercial Distribution |
| GS1 | 26938119331129 [Package] Package: Carton [2 Units] In Commercial Distribution |
| BYD | Condenser, Heat And Moisture (Artificial Nose) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2022-11-18 |
| 16938119329433 - NA | 2022-11-28 |
| 16938119329464 - NA | 2022-11-28 |
| 16938119329495 - NA | 2022-11-28 Anesthetic Mask(Bending edge model:2#) |
| 16938119329525 - NA | 2022-11-28 Anesthetic Mask(Bending edge model:3#) |
| 16938119329556 - NA | 2022-11-28 Anesthetic Mask(Bending edge model:4#) |
| 16938119329587 - NA | 2022-11-28 Anesthetic Mask(Bending edge model:5#) |
| 16938119329617 - NA | 2022-11-28 Anesthetic Mask( Detachable model:3#) |
| 16938119329648 - NA | 2022-11-28 Anesthetic Mask( Detachable model:4#) |