Catalog Number

20325-243

Brand Name

ERBE

Version/Model Number

20325-243

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

K162152,K162152,K162152

Product Code

FEQ

Product Code Name

PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Public Device Record Key

68667fb9-3f16-4053-bad6-102d08f38c88

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

December 14, 2016

Package DI Number

04050147020696

Quantity per Package

5

Contains DI Package

04050147020689

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Level: 2