Catalog Number

-

Brand Name

Drive

Version/Model Number

15500B

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

FOX

Product Code Name

STAND, INFUSION

Public Device Record Key

c2777d79-e1ed-434f-9e96-07aecc99415a

Public Version Date

February 18, 2020

Public Version Number

1

DI Record Publish Date

February 10, 2020

Package DI Number

00822383319094

Quantity per Package

2

Contains DI Package

00822383119090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-