Catalog Number

CMD3

Brand Name

N/A

Version/Model Number

CMD3

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"

Yes

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

K031896,K031896

Product Code

MNS

Product Code Name

Ventilator, Continuous, Non-Life-Supporting

Public Device Record Key

0370c008-0e43-47c3-8f15-9c626bea379c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 03, 2017

Package DI Number

10607411942287

Quantity per Package

30

Contains DI Package

00607411942280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-