Catalog Number

-

Brand Name

NOVATEMP

Version/Model Number

10-1655-001

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"

Yes

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

KRI

Product Code Name

Accessory Equipment, Cardiopulmonary Bypass

Public Device Record Key

c2119c91-81eb-4955-8cf0-03edda0c154b

Public Version Date

March 15, 2021

Public Version Number

4

DI Record Publish Date

January 02, 2017

Package DI Number

20817499020198

Quantity per Package

3

Contains DI Package

10817499020191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE