Catalog Number

-

Brand Name

NOVATEMP

Version/Model Number

10-1620-001

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

BZT

Product Code Name

Stethoscope, Esophageal, With Electrical Conductors

Public Device Record Key

3d0db60d-746f-47f8-9b79-1dcf5f61a59f

Public Version Date

March 15, 2021

Public Version Number

4

DI Record Publish Date

December 28, 2016

Package DI Number

20817499020075

Quantity per Package

4

Contains DI Package

10817499020078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE