Catalog Number

680072

Brand Name

CRITICATH(TM) SP5537H-13 PACING CATHETER

Version/Model Number

680072

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)

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

KRB

Product Code Name

Probe, Thermodilution

Public Device Record Key

ae37d688-29e6-4aea-b77c-e2a6c68b193d

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

50886333600729

Quantity per Package

30

Contains DI Package

00886333600724

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

tyvek tray