| Primary Device ID | 00709078001369 |
| NIH Device Record Key | 61c20187-a756-4992-8b4c-e23414e4efce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vibralung Patient Kit |
| Version Model Number | 9600 |
| Company DUNS | 092673953 |
| Company Name | WESTMED, INC. |
| 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 | false |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00709078001369 [Primary] |
| GS1 | 10709078001366 [Package] Package: [1 Units] In Commercial Distribution |
| BYI | Percussor, Powered-Electric |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-15 |
| 00709078001369 | 1 each: Standard Y Adapter, Aerosol Y-Adapter, Hand-held Transducer (HHT) assembly with screw-on |
| 10709078001359 | 9600-10 |