Duns Number:207372814
Device Description: The Accuflex Pro+ Digital Thermometer provides a quick and accurate reading of an individu The Accuflex Pro+ Digital Thermometer provides a quick and accurate reading of an individual’s body temperature. It features a comfortable and flexible tip along with beeper and memory functions. It is intended to measure body temperature orally, rectally, or under the arm. Perfect for clinical or home use for people of all ages.
Catalog Number
-
Brand Name
Physiologic Accuflex Pro+ Digital Thermometer
Version/Model Number
016-658
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
-
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
K183393,K183393,K183393
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
eb2f4ab5-dcba-4088-a414-5e6f4ccc5db7
Public Version Date
August 09, 2021
Public Version Number
1
DI Record Publish Date
August 01, 2021
Package DI Number
00057565976585
Quantity per Package
6
Contains DI Package
00057565166580
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |