AMSure® Sodium Chloride Inhalation Solution, USP (0.9% NaCl), 5mL - AMSure® Sodium Chloride Inhalation Solution, USP - AMSINO INTERNATIONAL, INC.

Duns Number:825673239

Device Description: AMSure® Sodium Chloride Inhalation Solution, USP (0.9% NaCl), 5mL

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More Product Details

Catalog Number

ASR0059

Brand Name

AMSure® Sodium Chloride Inhalation Solution, USP (0.9% NaCl), 5mL

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

6be2fe12-886f-40a8-9f81-ad8865a3ad96

Public Version Date

May 20, 2019

Public Version Number

1

DI Record Publish Date

May 12, 2019

Additional Identifiers

Package DI Number

40704411010303

Quantity per Package

10

Contains DI Package

30704411010306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"AMSINO INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 89
2 A medical device with a moderate to high risk that requires special controls. 411
U Unclassified 1