Catalog Number

301-145EA

Brand Name

Curaplex

Version/Model Number

301-145EA

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BYX

Product Code Name

TUBING, PRESSURE AND ACCESSORIES

Public Device Record Key

eee2c17d-0705-4f56-ae1d-659bb6710978

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

February 10, 2019

Package DI Number

00818834021968

Quantity per Package

50

Contains DI Package

00818834020886

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS