Catalog Number

-

Brand Name

SourceMark

Version/Model Number

SM4504NP

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)

-

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

9750a65f-e7a0-435c-884e-df45f58c64a9

Public Version Date

November 24, 2020

Public Version Number

1

DI Record Publish Date

November 16, 2020

Package DI Number

10813799004831

Quantity per Package

50

Contains DI Package

00813799004827

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case