FDA.reportPublic FDA data

BioStamp® nPoint

Primary DI
G012BRCA02
Brand
BioStamp® nPoint
Company
Medidata Solutions, Inc.
Model
BRCA02
Device description
Adhesive with hydrogel
Published
2021-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
G012MC0009PackageHIBCC42In Commercial Distribution
B493BRCA02PreviousHIBCC0
G012BRCA02PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/rehabilitation softwareA software package intended to be used by patients and clinicians to receive and display a patient’s physical exercise/movement/action data [e.g., kinesiology/gait data (walking speed or distance)] to facilitate analysis as part of physical assessment/rehabilitation. It is intended to be used while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology recorder (ambulatory or implantable). 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 and/or enable viewing of patient performance data.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
877-338-2778patientcloudsupport@mdsol.com

Regulatory Flags#

DUNS number
840371087
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G012SW0027BioStamp nPoint™SW-00272021-04-01

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