Sodium Chloride Inhalation Solution, USP, 7%-4mL

FDA UDI

Class II (US FDA UDI)

by Lifestar Pharma Llc

Identity

Trade Name: Sodium Chloride Inhalation Solution, USP, 7%-4mL FDA UDI
Generic Name: Inhalation therapy saline solution, hypertonic FDA UDI
Device Name: Carton with 60 vials; 7% Sodium chloride inhalation solution, made to USP, 4mL vial, sterile, preservative free, non-pyrogenic. FDA UDI
Model / Reference: 4mL FDA UDI
Description: Carton with 60 vials; 7% Sodium chloride inhalation solution, made to USP, 4mL vial, sterile, preservative free, non-pyrogenic. FDA UDI

Identifiers

Primary DI / UDI-DI: 00370756664604 FDA UDI
510(k) Number: K232523 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Inhalation therapy saline solution, hypertonic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Inhalation therapy saline solution, hypertonic

Sodium Chloride Inhalation Solution, USP, 7%-4mL by Lifestar Pharma Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Inhalation therapy saline solution, hypertonic.

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McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
Sodium Chloride Inhalation Solution, USP 3% — Nephron Pharmaceuticals Corp. · Class II
MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV — RITEDOSE PHARMACEUTICALS, LLC · Class II
MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class II

Cleared under the same submission

K232523 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Lifestar Pharma Llc

Sources (1)

FDA UDI b416aae7-aa83-4b58-b6e1-c72818a01029 36 fields · synced May 30, 2026