Catalog Number

-

Brand Name

Puritan Bennett

Version/Model Number

4-074613-00

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

CBK

Product Code Name

VENTILATOR, CONTINUOUS, FACILITY USE

Public Device Record Key

4b56e512-2df4-4d5d-ad46-f7a2a8fd4abb

Public Version Date

September 22, 2022

Public Version Number

7

DI Record Publish Date

June 07, 2016

Package DI Number

10884521148161

Quantity per Package

2

Contains DI Package

20884521148168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE