Identity
- Trade Name
- BioButton (In Bulk Packaging) 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. P/N: BBR-B-I-N FDA UDI
- Model / Reference
- BIOST0604F v2.1 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. P/N: BBR-B-I-N FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005949282 FDA UDI
- 510(k) Number
- K212957 FDA UDI
- FDA Product Code
- DRG FDA UDINDC FDA UDI
- GMDN Term
- Wearable multiple physiological parameter recorder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 FDA UDI868.1890 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
Yes
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
MR Unsafe FDA UDI
Category: Wearable multiple physiological parameter recorder, reusable
BioButton (In Bulk Packaging) by Biointellisense, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212957 also covers:
- BioButton At-Home Kit with Adhesives and BioButton — BIOINTELLISENSE INC.
- BioButton At-Home Kit with Power Adaptor — BIOINTELLISENSE INC.
- BioButton At-Home Kit with Power Adaptor and Adhesives — BIOINTELLISENSE INC.
- BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton — BIOINTELLISENSE INC.
- BioButton At-Home Kit — BIOINTELLISENSE, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biointellisense, Inc.
Sources (1)
- FDA UDI 419f665c-daf6-49bd-914c-389ef6f085a2 36 fields · synced Jun 8, 2026