Duns Number:059247507
Device Description: Convenience of Reusable and Disposable Forehead Thermometers.4 Disposable ThermoStrips - 1 Convenience of Reusable and Disposable Forehead Thermometers.4 Disposable ThermoStrips - 108152360208791 Reusable ThermoStrip - 10815236020848
Catalog Number
RL323-06
Brand Name
ThermoStrip
Version/Model Number
RL323-06
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
Yes
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
KPD
Product Code Name
Strip, Temperature, Forehead, Liquid Crystal
Public Device Record Key
ed255302-b3b5-45af-b200-2fb8588c376c
Public Version Date
February 24, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10815236020855
Quantity per Package
12
Contains DI Package
00815236020858
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Poly Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |