PEP-S
GUDID 00744229100003
PEP-S Positive Expiratory Pressure System
PARI RESPIRATORY EQUIPMENT, INC.
Mechanical positive pressure airway secretion-clearing device| Primary Device ID | 00744229100003 |
| NIH Device Record Key | 3f90d82a-3af2-4f0e-9316-31c4ddf4691e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PEP-S |
| Version Model Number | 018F63 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00744229100003 [Package] Contains: 00744229180128 Package: carton [12 Units] In Commercial Distribution |
| GS1 | 00744229180128 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090829
FDA Product Code
| BWF | Spirometer, Therapeutic (Incentive) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-30 |
Devices Manufactured by PARI RESPIRATORY EQUIPMENT, INC.
| 00744229100850 - Vortex | 2024-05-08 Mask, VORTEX, Pediatric Small |
| 00744229100867 - Vortex | 2024-05-08 Mask, VORTEX, Pediatric Medium |
| 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 |
Trademark Results [PEP-S]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEP-S 74378158 1856477 Dead/Cancelled |
AMERSHAM PHARMACIA BIOTECH AB 1993-04-12 |
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