Catalog Number

4009-ER

Brand Name

Starboard Temperature Probes

Version/Model Number

4009-ER

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

K111050,K111050

Product Code

BZT

Product Code Name

Stethoscope, Esophageal, With Electrical Conductors

Public Device Record Key

d3a04ea6-508b-49e7-8e4b-490a764d7317

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2016

Package DI Number

10850933007068

Quantity per Package

35

Contains DI Package

00850933007061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack