Duns Number:080728314
Device Description: Finished Good, VitalSense, Temperature Dermal Patch
Catalog Number
500-0200-00
Brand Name
VitalSense
Version/Model Number
VITALSENSE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 9999
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K033534
Product Code
FLL
Product Code Name
Thermometer, electronic, clinical
Public Device Record Key
e7caad68-4230-4fb8-acfc-64e63193d57d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 09, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 151 |
2 | A medical device with a moderate to high risk that requires special controls. | 3279 |