Catalog Number

22227

Brand Name

HU-FRIEDY

Version/Model Number

22227

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 19, 2022

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

-

Product Code

EKG

Product Code Name

CONDENSER, AMALGAM AND FOIL, OPERATIVE

Public Device Record Key

ab289123-78dc-4205-97df-61d6c0df3b73

Public Version Date

January 20, 2022

Public Version Number

2

DI Record Publish Date

November 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-