Saline

GUDID 00744229307129

7% Hypertonic Saline

PARI RESPIRATORY EQUIPMENT, INC.

Inhalation therapy saline solution, hypertonic
Primary Device ID00744229307129
NIH Device Record Key051941c8-709c-4ec4-9026-8725af4c774e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSaline
Version Model Number300F7010
Company DUNS804736098
Company NamePARI RESPIRATORY EQUIPMENT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100744229307129 [Package]
Contains: 00744229307600
Package: carton [12 Units]
In Commercial Distribution
GS100744229307600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-17

Devices Manufactured by PARI RESPIRATORY EQUIPMENT, INC.

00744229100850 - Vortex2024-05-08 Mask, VORTEX, Pediatric Small
00744229100867 - Vortex2024-05-08 Mask, VORTEX, Pediatric Medium
00744229510529 - Vortex2024-05-06 Vortex Nonelectrostatic Holding Chmbr
00744229510536 - Vortex2024-05-01 Vortex w Pediatric Mask Small
00744229510543 - Vortex2024-05-01 Vortex w Pediatric Mask Medium
00744229510512 - Vortex2024-05-01 Vortex Hospital Package
00744229510598 - Vortex2024-05-01 Vortex w Adult Mask
00744229230205 - LC Sprint Star2023-08-18 LC Sprint Star Neb Set

Trademark Results [Saline]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SALINE
SALINE
87413796 not registered Dead/Abandoned
Masco Cabinetry LLC
2017-04-17
SALINE
SALINE
78263411 not registered Dead/Abandoned
Alkamedia Records, Inc.
2003-06-17
SALINE
SALINE
71551327 0520204 Dead/Expired
SINCLAIR REFINING COMPANY
1948-03-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.