Catalog Number

-

Brand Name

Puritan Bennett

Version/Model Number

Y-6464

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

K002686,K002686

Product Code

CBK

Product Code Name

VENTILATOR, CONTINUOUS, FACILITY USE

Public Device Record Key

0302c481-13b3-4acd-8f5d-b383a0a9bf58

Public Version Date

October 24, 2022

Public Version Number

8

DI Record Publish Date

August 03, 2017

Package DI Number

10884521706972

Quantity per Package

10

Contains DI Package

20884521706979

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE