Catalog Number

20325-308

Brand Name

ERBE

Version/Model Number

20325-308

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

cb602c84-5f72-4916-b26c-fa571e3a5b47

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

December 15, 2016

Package DI Number

04050147013636

Quantity per Package

7

Contains DI Package

04050147013025

Package Discontinue Date

January 16, 2017

Package Status

Not in Commercial Distribution

Package Type

Level: 1