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BioButton (Reprocessed, NF Version)

FDA UDI

Class II (US FDA UDI)

by Biointellisense, Inc.

Identity

Trade Name
BioButton (Reprocessed, NF Version) FDA UDI
Generic Name
Wearable multiple physiological parameter recorder, reusable FDA UDI
Device Name
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. Note: this model is reprocessed device. FDA UDI
Model / Reference
BBR-B-I-R (BBR-B-NF-I-R) FDA UDI
Description
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. Note: this model is reprocessed device. FDA UDI

Identifiers

Catalog Number
n/a FDA UDI
Primary DI / UDI-DI
00850005949565 FDA UDI
FDA Product Code
DRG FDA UDI
NDC FDA UDI
GMDN Term
Wearable multiple physiological parameter recorder, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2910 FDA UDI
868.1890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Wearable multiple physiological parameter recorder, reusable

BioButton (Reprocessed, NF Version) by Biointellisense, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable multiple physiological parameter recorder, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biointellisense, Inc.

Sources (1)

  • FDA UDI 2378f51e-076b-42eb-939d-0001741d4a44 35 fields · synced Jun 8, 2026