| Primary Device ID | 00744229100423 |
| NIH Device Record Key | a86206ca-c591-4d08-97fe-5e61998fe217 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PEP |
| Version Model Number | 044B4612 |
| Company DUNS | 804736098 |
| Company Name | PARI RESPIRATORY EQUIPMENT, 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00744229100423 [Package] Contains: 00744229440383 Package: carton [12 Units] In Commercial Distribution |
| GS1 | 00744229440383 [Primary] |
| BWF | Spirometer, Therapeutic (Incentive) |
| 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 | 2016-09-30 |
| 00744229510529 - Vortex | 2024-05-06 Vortex Nonelectrostatic Holding Chmbr |
| 00744229510536 - Vortex | 2024-05-01 Vortex w Pediatric Mask Small |
| 00744229510543 - Vortex | 2024-05-01 Vortex w Pediatric Mask Medium |
| 00744229510512 - Vortex | 2024-05-01 Vortex Hospital Package |
| 00744229510598 - Vortex | 2024-05-01 Vortex w Adult Mask |
| 00744229230205 - LC Sprint Star | 2023-08-18 LC Sprint Star Neb Set |
| 00744229440703 - Wing Tip | 2023-07-06 Tubing, Wing Tip, Safety Core |
| 00744229100706 - Proneb Max | 2023-06-29 Proneb Max, 5 Yr, LC Sprint |