Duns Number:006961700
Device Description: UP&UP Ear/Forehead Digital Infrared Digital Thermometer
Catalog Number
48-343
Brand Name
UP&UP
Version/Model Number
094-06-0014
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100488,K100488,K100488
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
9006c94d-aa9a-417d-b950-eed805589b3a
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
November 24, 2020
Package DI Number
30845717010017
Quantity per Package
3
Contains DI Package
00845717010016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Intermediate
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |
| U | Unclassified | 12 |