Catalog Number

4005629

Brand Name

ENDOGATOR

Version/Model Number

4005629

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

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

K033695,K220395,K033695,K220395,K033695,K220395,K033695,K220395

Product Code

FEQ

Product Code Name

PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Public Device Record Key

2d66308e-19e6-4ee3-ac63-443ae99c8bd7

Public Version Date

August 08, 2022

Public Version Number

1

DI Record Publish Date

July 29, 2022

Package DI Number

40677964031593

Quantity per Package

5

Contains DI Package

40677964031616

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case