Catalog Number

-

Brand Name

Drive

Version/Model Number

610-12B

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)

-

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

45c723cd-e2d7-4014-ad3c-47dac21c0371

Public Version Date

June 08, 2021

Public Version Number

9

DI Record Publish Date

September 16, 2016

Package DI Number

10822383295982

Quantity per Package

12

Contains DI Package

00822383295985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-