Catalog Number

ZIT-1020

Brand Name

InfuseIT

Version/Model Number

ZIT-1020

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

19a3f94c-7310-4beb-9928-83b77d7bd12c

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10607411913393

Quantity per Package

5

Contains DI Package

00607411913396

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-