| Primary Device ID | 10709078005968 |
| NIH Device Record Key | dc108cd2-09e2-4efc-b826-761be4a1ca83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Composite Respiratory Kit |
| Version Model Number | 0798 |
| Company DUNS | 092673953 |
| Company Name | WESTMED, INC. |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00070907805961 [Primary] |
| GS1 | 00709078005961 [Primary] |
| GS1 | 10709078005968 [Package] Contains: 00709078005961 Package: [10 Units] In Commercial Distribution |
| OGL | Oxygen Administration Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-01-27 |
| Device Publish Date | 2018-09-25 |
| 10709078005708 | O2 Composite Kit |
| 10709078003612 | 1 - Packaged 50' O2 Tubing (0052), 6 - Packaged Soft Cannula with 7' Tubing (0556), 1 - Barbed C |
| 10709078005968 | 0798 |
| 10709078007788 | Composite Respiratory Kit |