| Primary Device ID | 10709078003896 |
| NIH Device Record Key | c39a8e11-fd21-4834-8160-adc01b7fd275 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Composite Kit |
| Version Model Number | 0794 |
| 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 | true |
| 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 | 00709078003899 [Primary] |
| GS1 | 10709078003896 [Package] Contains: 00709078003899 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 | 2018-03-29 |
| Device Publish Date | 2017-05-26 |
| 10709078003896 | Composite Kit,High Flow Humidifier,Adult Cannula w/25'Tubin |
| 10709078003025 | Composite Kit, High Flow Humidifier, Adult Cannula, 14' Tubing |
| 00709078003011 | Composite Kit, High Flow Humidifier, Adult Cannula, 7' Tubing |