Catalog Number

20325-331

Brand Name

ERBE

Version/Model Number

20325-331

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K132340,K132340,K132340

Product Code

FEQ

Product Code Name

PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Public Device Record Key

57552dbf-0ccc-4f93-935c-a36ca8f48b3c

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

December 15, 2016

Package DI Number

04050147013728

Quantity per Package

5

Contains DI Package

04050147013711

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Level: 2