Catalog Number

-

Brand Name

BEAMER AVEO IRRIGATION PUMP BOTTLE HOLDER (US/EU) REPLACEMENT PART

Version/Model Number

PUMP-3

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

K210618,K210618

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

18002ed3-803d-4299-9f4a-bf7959b837c7

Public Version Date

March 25, 2022

Public Version Number

3

DI Record Publish Date

February 22, 2022

Package DI Number

06946332803718

Quantity per Package

10

Contains DI Package

06946332803701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box