Catalog Number

-

Brand Name

ENDOGATOR

Version/Model Number

100136

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 2022

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

Yes

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

K220395,K033695,K220395,K033695,K220395,K033695

Product Code

FEQ

Product Code Name

PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Public Device Record Key

6cbf0c41-7244-4a99-acda-6dd30d66ca01

Public Version Date

August 01, 2022

Public Version Number

11

DI Record Publish Date

September 22, 2016

Package DI Number

20677964058473

Quantity per Package

50

Contains DI Package

00677964058479

Package Discontinue Date

July 29, 2022

Package Status

Not in Commercial Distribution

Package Type

Case