Catalog Number

20325-208

Brand Name

ERBE

Version/Model Number

20325-208

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

K132340,K132340,K132340,K132340,K132340

Product Code

FEQ

Product Code Name

PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Public Device Record Key

0a51170a-4d59-4c6a-83b9-b9c286facdff

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

December 16, 2016

Package DI Number

04050147013254

Quantity per Package

7

Contains DI Package

04050147012837

Package Discontinue Date

January 16, 2017

Package Status

Not in Commercial Distribution

Package Type

Level: 1