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Sodium Chloride Inhalation Solution, USP, 0.45% 3 mL UDV

FDA UDI

Class II (US FDA UDI)

by Ritedose Pharmaceuticals, Llc

Identity

Trade Name
Sodium Chloride Inhalation Solution, USP, 0.45% 3 mL UDV FDA UDI
Generic Name
Inhalation therapy saline solution, isotonic FDA UDI
Model / Reference
3 mL FDA UDI

Identifiers

Primary DI / UDI-DI
00376204400039 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Inhalation therapy saline solution, isotonic

Sodium Chloride Inhalation Solution, USP, 0.45% 3 mL UDV by Ritedose Pharmaceuticals, Llc — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Inhalation therapy saline solution, isotonic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ritedose Pharmaceuticals, Llc

Sources (1)

  • FDA UDI 625c438b-4900-4775-90e4-146369ed09e1 34 fields · synced May 30, 2026