FDA.reportPublic FDA data

BioDashboard

Primary DI
00850005949466
Brand
BioDashboard
Company
BIOINTELLISENSE, INC.
Model
SW-BDB
Catalog number
N/A
Device description
BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data and log assessments. The Device displays data and notifies healthcare professionals when physiological data fall outside clinician specified parameters. The data from the Device are intended as an aid to diagnosis, diseases management, and treatment. The Device has the ability to allow the clinician to configure the parameters for notifications. Healthcare professionals are the intended operators of this device. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended for critical care.
Published
2025-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00850005949466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005949466008500059494668500059494660850005949466

GMDN Terms#

Term, Definition table
TermDefinition
Clinical decision management support softwareAn application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, guidelines links) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. It may also be referred to as clinical decision support (CDS) software, and may be a locally-installed program, web-based, or mobile app.

Contacts#

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

Regulatory Flags#

DUNS number
116984478
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005949671BioButton Charging StationCRG-BBM-18299N/A2025-11-19
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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