Catalog Number

D205F7

Brand Name

SWAN-GANZ PACING TD CATHETER

Version/Model Number

D205F7

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

-

Product Code

LDF

Product Code Name

Electrode, Pacemaker, Temporary

Public Device Record Key

ccbd5f9b-c851-4c45-92e5-7709f6dced27

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-