Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

EK-1

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

-

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

BYX

Product Code Name

TUBING, PRESSURE AND ACCESSORIES

Public Device Record Key

b240e8c7-7437-47f6-b842-c9907770a00b

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

June 21, 2019

Package DI Number

50822383116469

Quantity per Package

25

Contains DI Package

00822383116464

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-