Catalog Number

1105XB

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

-

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

033befaa-f5d7-45b5-bd3c-c22c0442113b

Public Version Date

September 27, 2022

Public Version Number

4

DI Record Publish Date

August 20, 2019

Package DI Number

30841522127872

Quantity per Package

5

Contains DI Package

10841522127878

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX