Catalog Number

-

Brand Name

Drive

Version/Model Number

18580

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

K973282,K973282

Product Code

CCL

Product Code Name

ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Public Device Record Key

e81b0063-01b9-4eda-abe9-201555adb011

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

10822383135455

Quantity per Package

10

Contains DI Package

00822383135458

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-