Catalog Number

-

Brand Name

Drive

Version/Model Number

18600-KITN

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)

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

c6e5d382-19ad-4869-a9a9-fb97523c94d8

Public Version Date

June 08, 2021

Public Version Number

5

DI Record Publish Date

July 10, 2017

Package DI Number

50822383286575

Quantity per Package

50

Contains DI Package

00822383286570

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-