Catalog Number

1948-52

Brand Name

Isoflex™

Version/Model Number

1948-52

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

P960030

Product Code

NVY

Product Code Name

Permanent defibrillator electrodes

Public Device Record Key

5d95bcb2-7a13-4400-be8a-49160183cd1d

Public Version Date

April 28, 2022

Public Version Number

6

DI Record Publish Date

January 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-