Duns Number:783518983
Device Description: Infrared Thermometer
Catalog Number
-
Brand Name
Quick Temp Infrared Thermometer
Version/Model Number
CK-T1501
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K193253,K193253
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
77b055ad-76d2-48e3-aacc-41e17c270c78
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
July 31, 2020
Package DI Number
10850632007598
Quantity per Package
50
Contains DI Package
00850632007591
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
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 |