Saline
GUDID 00744229307129
7% Hypertonic Saline
PARI RESPIRATORY EQUIPMENT, INC.
Inhalation therapy saline solution, hypertonic| Primary Device ID | 00744229307129 |
| NIH Device Record Key | 051941c8-709c-4ec4-9026-8725af4c774e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Saline |
| Version Model Number | 300F7010 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00744229307129 [Package] Contains: 00744229307600 Package: carton [12 Units] In Commercial Distribution |
| GS1 | 00744229307600 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070498
FDA Product Code
| CAF | Nebulizer (Direct Patient Interface) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-17 |
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 [Saline]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SALINE 87413796 not registered Dead/Abandoned |
Masco Cabinetry LLC 2017-04-17 |
 SALINE 78263411 not registered Dead/Abandoned |
Alkamedia Records, Inc. 2003-06-17 |
 SALINE 71551327 0520204 Dead/Expired |
SINCLAIR REFINING COMPANY 1948-03-05 |
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