Catalog Number

20325-307

Brand Name

ERBE

Version/Model Number

20325-307

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

Product Code

FEQ

Product Code Name

PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Public Device Record Key

6d4a0836-5a31-40fa-94d3-41d3df9935a3

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

February 20, 2017

Package DI Number

04050147021105

Quantity per Package

10

Contains DI Package

04050147013018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Level: 1