Duns Number:029351079
Device Description: 8001 Series Esophageal/Rectal Temperature Probe
Catalog Number
8001-063-412
Brand Name
8001 Series Esophageal/Rectal Temperature Probe
Version/Model Number
8001-063-412
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
9af78aa2-7908-45c3-ac07-f79c0e6d8913
Public Version Date
October 19, 2018
Public Version Number
3
DI Record Publish Date
July 01, 2016
Package DI Number
H29780010634122
Quantity per Package
10
Contains DI Package
H29780010634121
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |