Catalog Number

301-MTM310EA

Brand Name

Curaplex

Version/Model Number

301-MTM310EA

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)

-

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

92aa427f-71d3-4e1a-947c-310842a6ce32

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

June 20, 2017

Package DI Number

00818834020404

Quantity per Package

5

Contains DI Package

00812574029819

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX