Catalog Number

MCV100-B

Brand Name

Life Support Products

Version/Model Number

MCV100-B

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

K080063

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Public Device Record Key

63c1b895-6d69-4530-9b58-f6bd29befdf2

Public Version Date

January 13, 2020

Public Version Number

4

DI Record Publish Date

November 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-