Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL

FDA UDI

Class II (US FDA UDI)

by Mylan Pharmaceuticals Inc.

Identity

Trade Name: Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL FDA UDI
Generic Name: Inhalation therapy saline solution, hypertonic FDA UDI
Device Name: The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen free. 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 single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen free. 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: 00303786987894 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, 0.9% 15 mL 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
MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class II

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 a7df9548-0e39-4428-80f0-51e21a32dd97 35 fields · synced May 30, 2026