Duns Number:003530786
Device Description: The Truer Medical disposable Esophageal Stethoscope with TemperatureSensor is used in a su The Truer Medical disposable Esophageal Stethoscope with TemperatureSensor is used in a surgical setting for monitoring temperature, as well as,heart and lung sounds of anesthetized patients. Inserted in the esophagus,the stethoscope provides an accurate measurement of core bodytemperature, as well as, transmitting clear heart and lung sounds to theanesthesiologist.
Catalog Number
ES 9400
Brand Name
Truer Medical, Inc.
Version/Model Number
ES 9400
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
K092716,K092716,K092716,K092716,K092716
Product Code
BZT
Product Code Name
Stethoscope, Esophageal, With Electrical Conductors
Public Device Record Key
2452febd-4e51-46e8-8a05-82759c7daa14
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 06, 2016
Package DI Number
40859290006005
Quantity per Package
6
Contains DI Package
20859290006001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |