Catalog Number

-

Brand Name

Baxter

Version/Model Number

0600044

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

2ba4ebc2-a7ae-47cd-b3d2-c77de5848c05

Public Version Date

April 23, 2021

Public Version Number

1

DI Record Publish Date

April 15, 2021

Package DI Number

10815634020815

Quantity per Package

5

Contains DI Package

00815634020818

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack