FDA.reportPublic FDA data

BioStamp® nPoint

Primary DI
G012MC00022
Brand
BioStamp® nPoint
Company
Medidata Solutions, Inc.
Model
MC00022
Device description
Clinical Investigations Kit containing BRCS02 Wearable Sensor Patch, BRCD02 Smart Charger, BSPS01 Medical Power Supply, BRCA05 Adhesive Applicator, BRCP03 Phone
Published
2021-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
IKNElectromyograph, Diagnostic
LELDevice, Sleep Assessment
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
IKNElectromyograph, DiagnosticPhysical Medicine2
LELDevice, Sleep AssessmentNeurology2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173510000BioStamp nPointMc10, Inc.2018-05-08DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G012MC00022PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/rehabilitation softwareA software package intended to be used to detect and display a patient’s physical exercise/movements/actions, and sometimes provide performance feedback, while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology ambulatory recorder, as part of physical assessment/rehabilitation. It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing patient performance data.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18666334328patientcloudsupport@mdsol.com

Regulatory Flags#

DUNS number
840371087
Device count
1
Kit
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G012BRCA02BioStamp® nPointBRCA022021-04-01
G012BRCA05BioStamp®BRCA052021-04-01
G012BRCD02BioStamp®BRCD02 2021-04-01
G012BRCP02BioStamp® nPointBRCP022021-04-01
G012BRCP03BioStamp®BRCP032021-04-01
G012BRCS02BioStamp®BRCS022021-04-01
G012BRCT01BioStamp nPoint™BRCT012021-04-01
G012BSPS01BioStamp®BSPS01 2021-04-01
G012MC0003BioStamp nPoint™MC00032021-04-01
G012MC0004BioStamp nPoint™MC-00042021-04-01
G012MC0005BioStamp nPoint™MC-00052021-04-01
G012MC0006BioStamp nPoint™MC-00062021-04-01
G012MC0007BioStamp nPoint™MC-0007 2021-04-01
G012MC0008BioStamp nPoint™MC-0008 2021-04-01
G012MC0012BioStamp nPoint™MC-00122021-04-01
G012MC0013BioStamp nPoint™MC-00132021-04-01
G012MC0014BioStamp nPoint™MC-00142021-04-01
G012MC0015BioStamp nPoint™MC-00152021-04-01
G012SW0025BioStamp nPoint™SW-0025 2021-04-01
G012SW0026BioStamp nPoint™SW-00262021-04-01

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Primary DI, Brand, Company table
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
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04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
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