Sodium Chloride Inhalation Solution, USP 7% 0487-9007-30

GUDID 30304879007308

NEPHRON PHARMACEUTICALS

Inhalation therapy saline solution, hypertonic
Primary Device ID30304879007308
NIH Device Record Key786b3f0e-239f-4945-bf36-fb7c4e0ba955
Commercial Distribution StatusIn Commercial Distribution
Brand NameSodium Chloride Inhalation Solution, USP 7%
Version Model Number900730
Catalog Number0487-9007-30
Company DUNS079160190
Company NameNEPHRON PHARMACEUTICALS
Device Count30
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 Numbertrue
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
GS100304879007307 [Primary]
GS110304879007304 [Package]
Contains: 00304879007307
Package: Case [30 Units]
In Commercial Distribution
GS130304879007308 [Unit of Use]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-07
Device Publish Date2024-02-28

Devices Manufactured by NEPHRON PHARMACEUTICALS

30304879003300 - Sodium Chloride Inhalation Solution, USP 3%2024-03-07
30304879007308 - Sodium Chloride Inhalation Solution, USP 7%2024-03-07
30304879007308 - Sodium Chloride Inhalation Solution, USP 7%2024-03-07
30304879301031 - Sodium Chloride Inhalation Solution, USP 0.9%2024-03-07
30304879301338 - Sodium Chloride Inhalation Solution, USP 0.9%2024-03-07
30304879302014 - Sodium Chloride Inhalation Solution, USP 0.9%2024-03-07

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