Catalog Number

-

Brand Name

Inovo

Version/Model Number

IN3625-R-2

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

CAN

Product Code Name

REGULATOR, PRESSURE, GAS CYLINDER

Public Device Record Key

e96ff979-9bda-48e3-a604-0caad71c4dea

Public Version Date

October 20, 2021

Public Version Number

3

DI Record Publish Date

May 27, 2020

Package DI Number

50822383003936

Quantity per Package

25

Contains DI Package

00822383003931

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton