Sodium Chloride Inhalation Solution, USP, 0.9%-5mL

GUDID 00370756662150

LIFESTAR PHARMA LLC

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Primary Device ID	00370756662150
NIH Device Record Key	158851ab-7c74-43a0-b1a2-8489f4fc0dc9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sodium Chloride Inhalation Solution, USP, 0.9%-5mL
Version Model Number	5mL
Company DUNS	080268943
Company Name	LIFESTAR PHARMA LLC
Device Count	100
DM Exempt	true
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	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-888-995-4337
Email	ProductComplaintLifestar@mankindpharma.com
Phone	1-888-995-4337
Email	ProductComplaintLifestar@mankindpharma.com
Phone	1-888-995-4337
Email	ProductComplaintLifestar@mankindpharma.com
Phone	1-888-995-4337
Email	ProductComplaintLifestar@mankindpharma.com
Phone	1-888-995-4337
Email	ProductComplaintLifestar@mankindpharma.com
Phone	1-888-995-4337
Email	ProductComplaintLifestar@mankindpharma.com
Phone	1-888-995-4337
Email	ProductComplaintLifestar@mankindpharma.com
Phone	1-888-995-4337
Email	ProductComplaintLifestar@mankindpharma.com
Phone	1-888-995-4337
Email	ProductComplaintLifestar@mankindpharma.com
Phone	1-888-995-4337
Email	ProductComplaintLifestar@mankindpharma.com
Phone	1-888-995-4337
Email	ProductComplaintLifestar@mankindpharma.com

Operating and Storage Conditions

Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370756662150 [Unit of Use]
GS1	00370756662990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K232523

FDA Product Code

CAF	Nebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-07
Device Publish Date	2024-04-29

Devices Manufactured by LIFESTAR PHARMA LLC

00370756661139 - Sodium Chloride Inhalation Solution, USP, 0.9%-3mL	2024-05-07
00370756662150 - Sodium Chloride Inhalation Solution, USP, 0.9%-5mL	2024-05-07
00370756662150 - Sodium Chloride Inhalation Solution, USP, 0.9%-5mL	2024-05-07
00370756663140 - Sodium Chloride Inhalation Solution, USP, 3%-4mL	2024-05-07
00370756664147 - Sodium Chloride Inhalation Solution, USP, 7%-4mL	2024-05-07 Carton with 60 vials; 7% Sodium chloride inhalation solution, made to USP, 4mL vial, sterile, preservative free, non-pyrogenic.