Catalog Number

-

Brand Name

Drive

Version/Model Number

CTU-18302GN

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

CAN

Product Code Name

REGULATOR, PRESSURE, GAS CYLINDER

Public Device Record Key

167598b2-b9d5-47a4-ba5d-959d06ae645a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 10, 2017

Package DI Number

50822383512889

Quantity per Package

20

Contains DI Package

00822383512884

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-