Duns Number:207372814
Device Description: The Accuflex 10 flexible digital thermometer provides clinically proven accuracy in just u The Accuflex 10 flexible digital thermometer provides clinically proven accuracy in just under 10 seconds. • For use orally, rectally or underarmAccurate within 0.2°F/0.1°CBeep signals peak temperatureWaterproof probe/ washable for easy cleaning
Catalog Number
016-635
Brand Name
Physiologic Accuflex 10 Flexible Digital Thermometer
Version/Model Number
016-635 Version 1
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
-
Prescription Use (Rx)
-
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
75fdd63d-7dcb-4100-b997-acbbbe194f1b
Public Version Date
August 21, 2020
Public Version Number
4
DI Record Publish Date
October 26, 2016
Package DI Number
05756595756000
Quantity per Package
6
Contains DI Package
00057565166351
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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. | 1 |