Catalog Number

37055US

Brand Name

Praxiject™ 0.9% NaCl

Version/Model Number

37055US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K171109,K171109,K171109

Product Code

NGT

Product Code Name

Saline, Vascular Access Flush

Public Device Record Key

0456c3aa-5c7e-4f32-833a-a8de981e7257

Public Version Date

July 09, 2020

Public Version Number

3

DI Record Publish Date

March 19, 2018

Package DI Number

30682686004513

Quantity per Package

6

Contains DI Package

20682686004516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton