Sodium Chloride Inhalation Solution, USP, 3% 15mL

FDA UDI

Class II (US FDA UDI)

by Mylan Pharmaceuticals Inc.

Identity

Trade Name: Sodium Chloride Inhalation Solution, USP, 3% 15mL FDA UDI
Generic Name: Inhalation therapy saline solution, hypertonic FDA UDI
Device Name: The 3% solutions are contained in a 15mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials. Primary DI number is for one carton of 50 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale. FDA UDI
Model / Reference: 15mL FDA UDI
Description: The 3% solutions are contained in a 15mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials. Primary DI number is for one carton of 50 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale. FDA UDI

Identifiers

Primary DI / UDI-DI: 00303786997893 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

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Manufacturing Date

FDA UDI

Category: Inhalation therapy saline solution, hypertonic

Sodium Chloride Inhalation Solution, USP, 3% 15mL by Mylan Pharmaceuticals Inc. — 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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Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV — RITEDOSE PHARMACEUTICALS, LLC · Class II
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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: Mylan Pharmaceuticals Inc.

Sources (1)

FDA UDI 6b1dc9fb-21c6-4caa-b702-3452f7ef50b0 35 fields · synced May 31, 2026