Duns Number:831531426
Device Description: 9FR ESOPHAGEAL/RECTAL TEMPERATURE PROBE WITH 400 SERIES THERMISTOR
Catalog Number
-
Brand Name
NOVATEMP
Version/Model Number
10-1610-001
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
-
Product Code
BZT
Product Code Name
Stethoscope, Esophageal, With Electrical Conductors
Public Device Record Key
84fbf84f-5878-4e11-aff1-4e040bf65dcd
Public Version Date
March 15, 2021
Public Version Number
4
DI Record Publish Date
January 02, 2017
Package DI Number
20817499020051
Quantity per Package
4
Contains DI Package
10817499020054
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |