Catalog Number

980X1ENDIUU-RMF

Brand Name

Puritan Bennett

Version/Model Number

980X1ENDIUU-RMF

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 02, 2019

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

K162738

Product Code

CBK

Product Code Name

VENTILATOR, CONTINUOUS, FACILITY USE

Public Device Record Key

0ff7f17e-c2f1-45ec-a383-f16adeca75a9

Public Version Date

August 14, 2020

Public Version Number

6

DI Record Publish Date

November 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-