Catalog Number

-

Brand Name

Mon-a-Therm

Version/Model Number

90041

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K811862,K811862,K811862

Product Code

BZT

Product Code Name

STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS

Public Device Record Key

af1269d6-3634-4ea8-85c4-32665edbd09b

Public Version Date

January 28, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

30884521031719

Quantity per Package

2

Contains DI Package

10884521031715

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE