Duns Number:080406332
Catalog Number
-
Brand Name
iLifeplus
Version/Model Number
JPD-FR200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
Issuing Agency
In HIBCC
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
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
63dfaf6c-d12b-4439-a48e-2cfad9224b59
Public Version Date
December 04, 2020
Public Version Number
5
DI Record Publish Date
March 07, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |