FDA.reportPublic FDA data

BioStamp®

Primary DI
G012BRCS02
Brand
BioStamp®
Company
Medidata Solutions, Inc.
Model
BRCS02
Device description
Wearable sensor patch
Published
2021-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B493BRCS02PreviousHIBCC0
G012BRCS02PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology/electromyographic sensor setA collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
1-866-633-4328patientcloudsupport@mdsol.com

Regulatory Flags#

DUNS number
840371087
Device count
1
Serial number
true
Expiration date on label
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
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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Primary DI, Brand, Company table
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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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