Catalog Number

904TGA

Brand Name

STATCORP

Version/Model Number

STATCORP

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

KZD

Product Code Name

INFUSOR, PRESSURE, FOR I.V. BAGS

Public Device Record Key

c8313ad0-dea3-429b-8f90-29dc77ba3760

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

August 20, 2019

Package DI Number

30841522127636

Quantity per Package

24

Contains DI Package

10841522127632

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX