Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

CPM-DEF2S

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

-

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

c3feba08-61a3-4644-a599-e2064846087f

Public Version Date

August 24, 2018

Public Version Number

1

DI Record Publish Date

July 24, 2018

Package DI Number

30092237620800

Quantity per Package

50

Contains DI Package

00092237620809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA