Catalog Number

1505834

Brand Name

BAXJECT II NTD

Version/Model Number

1505834

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

-

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

b689da4b-2974-468c-8e40-766dce246d75

Public Version Date

December 07, 2020

Public Version Number

5

DI Record Publish Date

September 28, 2016

Package DI Number

50642621003944

Quantity per Package

20

Contains DI Package

20642621003943

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case