Catalog Number

-

Brand Name

Beamer AVEO™ Irrigation Pump

Version/Model Number

AVEOPUMP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 03, 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

-

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

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

5219e063-276f-4a5e-9e1e-10bab5c6679a

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-