Duns Number:116984478
Device Description: The BioButton™ is a remote monitoring wearable device intended to collect physiological da The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients.
Catalog Number
SKU# B2-ST03-02-0-00-GY
Brand Name
BioButton
Version/Model Number
BIOST03020F
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191614,K191614
Product Code
DRG
Product Code Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Public Device Record Key
ba94a6bd-d778-426a-8f46-c4272fcade22
Public Version Date
July 04, 2022
Public Version Number
3
DI Record Publish Date
November 09, 2020
Package DI Number
10850005949104
Quantity per Package
165
Contains DI Package
00850005949107
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |