FDA.reportPublic FDA data

BioButton Charging Station

Primary DI
00850005949671
Brand
BioButton Charging Station
Company
BIOINTELLISENSE, INC.
Model
CRG-BBM-18299
Catalog number
N/A
Device description
The BioButton Charging Station is intended to be used by trained professionals to charge multiple compatible rechargeable wearable devices simultaneously in healthcare or other care facilities.The charger is not intended to be used at the patient home.This UDI is for Gen 2 design.
Published
2025-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241101000BioButton SystemBiointellisense, Inc.2024-09-26DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005949678PackageGS18In Commercial Distribution
00850005949671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000594967810850005949678
00850005949671008500059496718500059496710850005949671

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple physiological parameter recorder, reusableAn electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1 888-908-8804support@biointellisense.com

Regulatory Flags#

DUNS number
116984478
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005949466BioDashboardSW-BDBN/A2025-02-28
00850005949558BioButton (Reprocessed)BBR-B-I-Rn/a2025-02-19
00850005949565BioButton (Reprocessed, NF Version)BBR-B-I-R (BBR-B-NF-I-R)n/a2025-02-19
00850005949596BioButton Charging StationCRG-12685N/A2025-02-19
10850005949555BioButton (Reprocessed)BBR-B-I-Rn/a2025-02-19
10850005949562BioButton (Reprocessed, NF Version)BBR-B-I-R (BBR-B-NF-I-R)n/a2025-02-19
10850005949593BioButton Charging StationCRG-12685N/A2025-02-19
00850005949442BioButton Rechargeable Device, Multi-PatientBBRM-B-I-NN/A2025-02-11
10850005949449BioButton Rechargeable Device, Multi-PatientBBRM-B-I-NN/A2025-02-11
00850005949541BioButton Adhesive V2 (ADH-CS)ADH-CS-10771N/A2024-05-01
00850005949534BioButton Adhesive V2 (ADH-CS)ADH-CS-10771N/A2024-05-01
00850005949244BioButton Rechargeable Adhesives (ADD-HT)ADH-AC1-BBR-5-1-1-10N/A2022-07-20
00850005949299BioButton v3 (BBN-r, different batch)BIOST060402023-09-05
00850005949282BioButton (In Bulk Packaging)BIOST0604F v2.12023-07-03
00850005949312BioButton At-Home Kit with Power AdaptorKIT-BBR-3763-12023-11-16
00850005949343BioButton At-Home Kit with Power Adaptor, Adhesives and BioButtonKIT-BBR-3763-32023-11-16
00850005949367BioButton At-Home Kit with Adhesives and BioButtonKIT-BBR-3763-42023-11-16
00850005949381BioButton At-Home KitKIT-BBR-3763-22023-11-16
00850005949404BioButton At-Home Kit with Power Adaptor and Adhesives KIT-BBR-3763-52023-11-16
00850005949336BioButton At-Home Kit with Power AdaptorKIT-BBR-3763-12023-11-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809988780049Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E)Xandar Kardian Korea Inc.DRT2025-12-04
B353UB12511UbiqVue HolterLifesignals, Inc.DRG2025-04-22
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B353UA2251DA1UbiqVue Lifesignals, Inc.DRG2025-04-22
B353UA2251SA1UbiqVue Lifesignals, Inc.DRG2025-04-22
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDDRG2025-03-05
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B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DRT2024-12-19
B353UB25501UbiqVue MultiparameterLifesignals, Inc.DRG2024-11-29
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.DRG2024-06-19
07649996477019Sleepiz One+Sleepiz AGDRT2024-05-14
00195278697165PORTRAIT HSWXBGE Healthcare Finland OyDRG2024-04-30
00195278713193Portrait HUBXBGE Healthcare Finland OyDRG2024-04-30
08809988780001Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300)Xandar Kardian Korea Inc.DRT2024-01-19
00195278699916PORTRAIT AAB01GE Healthcare Finland OyDRG2023-10-26
00195278699923PORTRAIT MMP01GE Healthcare Finland OyDRG2023-10-26
B3944670063010WVSM Wireless Vital Signs MonitorATHENA GTX, INC.DRG2023-10-19
00195278120014PORTRAIT SBT01GE Healthcare Finland OyDRG2023-09-12
00195278223401PORTRAIT RRP01GE Healthcare Finland OyDRG2023-09-12
00195278093998PORTRAIT HUB01GE Healthcare Finland OyDRG2023-09-01
00195278110435PORTRAIT MMP01GE Healthcare Finland OyDRG2023-09-01
00195278201980PORTRAIT AAB01GE Healthcare Finland OyDRG2023-09-01
00195278264794PORTRAIT SpO2 P-SP01GE Healthcare Finland OyDRG2023-09-01
00195278264800PORTRAIT SpO2 P-W01GE Healthcare Finland OyDRG2023-09-01
00195278264824PORTRAIT SpO2 P-SE01GE Healthcare Finland OyDRG2023-09-01
00195278264831PORTRAIT SpO2 P-SA01GE Healthcare Finland OyDRG2023-09-01
00195278341129Portrait CSS01GE Medical Systems Information Technologies, Inc.DRG2023-09-01