Duns Number:116984478
Device Description: The BioSticker™ System is a wearable remote monitoring system intended for continuous coll The BioSticker™ System is a wearable remote monitoring system intended for continuous collection of physiological data in home and healthcare settings.
Catalog Number
-
Brand Name
BioSticker™
Version/Model Number
BIOST01021F
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K191614,K191614,K191614
Product Code
DRG
Product Code Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Public Device Record Key
32ff8831-9fd3-455c-8409-315a00e78e74
Public Version Date
May 20, 2020
Public Version Number
2
DI Record Publish Date
May 01, 2020
Package DI Number
10850005949005
Quantity per Package
10
Contains DI Package
00850005949008
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |