FDA.reportPublic FDA data

BioStamp®

Primary DI
B493BRCA02
Brand
BioStamp®
Company
MC10, INC.
Model
BRCA02
Device description
Adhesive with hydrogel
Published
2018-08-31
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B493MC0009PackageHIBCC42Not in Commercial Distribution
B493BRCA02PrimaryHIBCC0

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
Storage Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8572145630support@mc10inc.com

Regulatory Flags#

DUNS number
829221139
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
B493BRCA05BioStamp®BRCA052018-08-31
B493BRCD01BioStamp nPoint™BRCD012018-08-31
B493BRCD02BioStamp®BRCD022018-08-31
B493BRCP01BioStamp nPoint™BRCP012018-08-31
B493BRCP02BioStamp nPoint™BRCP022018-08-31
B493BRCP03BioStamp®BRCP032018-08-31
B493BRCS02BioStamp®BRCS022018-08-31
B493BRCT01BioStamp nPoint™BRCT012018-08-31
B493BSPS01BioStamp®BSPS012018-08-31
B493MC0003BioStamp nPoint™MC-00032018-08-31
B493MC0004BioStamp nPoint™MC-00042018-08-31
B493MC0005BioStamp nPoint™MC-00052018-08-31
B493MC0006BioStamp nPoint™MC-00062018-08-31
B493MC0007BioStamp nPoint™MC-00072018-08-31
B493MC0008BioStamp nPoint™MC-00082018-08-31
B493MC0011Kintinuum™MC-00112019-02-01
B493MC0012BioStamp nPoint™MC-00122018-08-31
B493MC0013BioStamp nPoint™MC-00132018-08-31
B493MC0014BioStamp nPoint™MC-00142018-08-31
B493MC0015BioStamp nPoint™MC-00152018-08-31

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