Catalog Number

-

Brand Name

Drive

Version/Model Number

22330-12

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAZ

Product Code Name

TUBING, NONINVASIVE

Public Device Record Key

f7a06d52-539c-461d-80e1-418ae4400b27

Public Version Date

October 20, 2021

Public Version Number

10

DI Record Publish Date

September 16, 2016

Package DI Number

10822383507429

Quantity per Package

12

Contains DI Package

00822383507422

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton