Catalog Number

200230B

Brand Name

ENDOGATOR

Version/Model Number

200230B

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

K033695,K220395,K033695,K220395

Product Code

FEQ

Product Code Name

PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Public Device Record Key

de928740-732e-44c2-98ff-0d3c025a8781

Public Version Date

May 11, 2022

Public Version Number

8

DI Record Publish Date

August 16, 2018

Package DI Number

20677964066188

Quantity per Package

20

Contains DI Package

00677964066184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case