Duns Number:059247507
Device Description: TempAlert II Liquid Crystal Temperature Trend Indicator - CE Marked
Catalog Number
8501-II-CE
Brand Name
TempAlert II
Version/Model Number
8501-II-CE
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)
-
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
0744809f-66c0-4034-a9b8-bbc8769740b9
Public Version Date
November 03, 2020
Public Version Number
1
DI Record Publish Date
October 26, 2020
Package DI Number
40815236020320
Quantity per Package
1
Contains DI Package
30815236020323
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Box
| 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 |