FDA.reportPublic FDA data

BioStamp® nPoint

Primary DI
G012MC0009
Brand
BioStamp® nPoint
Company
Medidata Solutions, Inc.
Model
BRCA02
Device description
Adhesive with hydrogel
Published
2021-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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 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 Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
840371087
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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