Duns Number:783518983
Device Description: Medical thermometer for measuring ear/ forehead/ object temperature/ ambient temperature o Medical thermometer for measuring ear/ forehead/ object temperature/ ambient temperature of human body via infrared rays emitted from the eardrum and skin surface. Measuring range: 32.0-42.9°C (89.6-109.2°F)
Catalog Number
-
Brand Name
Pro Comfort Tempa Check 4-in-1 Infrared thermometer
Version/Model Number
10059798
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
K181215,K181215,K181215
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
3a1b8b9c-a3a4-4afe-9f48-2ae4649be625
Public Version Date
March 06, 2020
Public Version Number
1
DI Record Publish Date
February 27, 2020
Package DI Number
10850632007345
Quantity per Package
50
Contains DI Package
00850632007348
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |