Catalog Number

057152P

Brand Name

NBIH™ Temporary Pacing Electrode Catheter

Version/Model Number

057152P

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

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

0e556e7f-7a61-4f29-a569-c4eb86a0c777

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 29, 2015

Package DI Number

10801741011471

Quantity per Package

5

Contains DI Package

00801741011474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA