Catalog Number

-

Brand Name

SourceMark

Version/Model Number

SM12400ES

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

K111050,K111050

Product Code

BZT

Product Code Name

Stethoscope, Esophageal, With Electrical Conductors

Public Device Record Key

c9d3581f-a512-4741-bb04-5b07e1f6f281

Public Version Date

July 17, 2020

Public Version Number

1

DI Record Publish Date

July 09, 2020

Package DI Number

10813799005456

Quantity per Package

35

Contains DI Package

00813799005442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case