Duns Number:011920774
Device Description: Quality Choice No Touch Infrared Thermometer
Catalog Number
QC-99430
Brand Name
QUALITY CHOICE
Version/Model Number
89-348
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
b5be0ee8-fb13-4367-923c-5e66819e0634
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
February 15, 2017
Package DI Number
30635515994301
Quantity per Package
3
Contains DI Package
00635515994300
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INTERMEDIATE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |