Duns Number:013029698
Catalog Number
-
Brand Name
Fever therometer
Version/Model Number
MP-IRT350-US
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
K131243,K131243,K131243
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
8d7bb7f6-7084-444f-96ba-992a832744a6
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
November 18, 2016
Package DI Number
00817746020281
Quantity per Package
1
Contains DI Package
00817746020274
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |