Catalog Number

-

Brand Name

Medex

Version/Model Number

MX4710

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)

-

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

ff462ac6-5778-4f00-a553-bffb634b1e05

Public Version Date

November 19, 2020

Public Version Number

4

DI Record Publish Date

January 13, 2020

Package DI Number

50351688507028

Quantity per Package

10

Contains DI Package

10351688507020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case