Duns Number:043081723
Device Description: Advocate Thermometer, Oral/Rectal, flexible tip probe, beep alert with 8 second results, l Advocate Thermometer, Oral/Rectal, flexible tip probe, beep alert with 8 second results, large digital display, "F"arenheit & "C"elsius, last memory recall, water resistant,
Catalog Number
145
Brand Name
ADVOCATE ORAL & RECTAL THERMOMETER
Version/Model Number
145
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101387,K101387,K101387
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
4520a555-241f-426c-8cbc-eddd6d9a7569
Public Version Date
December 07, 2020
Public Version Number
6
DI Record Publish Date
February 06, 2017
Package DI Number
20852982006358
Quantity per Package
96
Contains DI Package
10852982006351
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
145-C
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |