Catalog Number

-

Brand Name

IRRIGATOR/INSUFFLATOR

Version/Model Number

100130P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 21, 2018

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

K092429,K092429

Product Code

FEQ

Product Code Name

Pump, Air, Non-Manual, For Endoscope

Public Device Record Key

db3a1ee3-aa54-478d-b432-ad572aadc5b6

Public Version Date

October 08, 2018

Public Version Number

3

DI Record Publish Date

March 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-