Duns Number:207372814
Device Description: Accurate readings in as little as 5 seconds. •Color feverline alert indicates if the Accurate readings in as little as 5 seconds. •Color feverline alert indicates if the reading is normal or if it represents a mild or high fever.•Large, backlit screen displays temperature in °C or °F.•Beeps when reading is complete.•Professional accuracy within 0.1°C (0.2°F).•Waterproof gentle–flex tip for added comfort & safety.•Recalls last reading.•Can be used orally, rectally, under the arm or to take bath water temperature.•Auto shut-off for extended battery life
Catalog Number
016-651
Brand Name
Accuflex5 VU Thermometer, from Physio Logic
Version/Model Number
016-651
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
382c4279-ec2f-4216-b5f4-09559c9c34f6
Public Version Date
August 21, 2020
Public Version Number
3
DI Record Publish Date
May 16, 2018
Package DI Number
05756599923224
Quantity per Package
12
Contains DI Package
05756599922548
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |