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Sodium Chloride Inhalation Solution, USP 0.9%

FDA UDI

Class II (US FDA UDI)

by Nephron Pharmaceuticals Corp.

Identity

Trade Name
Sodium Chloride Inhalation Solution, USP 0.9% FDA UDI
Generic Name
Inhalation therapy saline solution, isotonic FDA UDI
Model / Reference
930103 FDA UDI

Identifiers

Catalog Number
0487-9301-03 FDA UDI
Primary DI / UDI-DI
00304879301030 FDA UDI
510(k) Number
K113033 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Inhalation therapy saline solution, isotonic 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Inhalation therapy saline solution, isotonic

Sodium Chloride Inhalation Solution, USP 0.9% by Nephron Pharmaceuticals Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inhalation therapy saline solution, isotonic.

Cleared under the same submission

K113033 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nephron Pharmaceuticals Corp.

Sources (1)

  • FDA UDI dba421eb-92e2-47b6-8b01-6f669b873241 35 fields · synced May 31, 2026