BioStamp nPoint™
GUDID G012MC0012
MC-0012 kit containing DIs G012BRCS02, G012BRCD02, BG012BRCP03, G012BSPS01, G012BRCA05
Medidata Solutions, Inc.
Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set| Primary Device ID | G012MC0012 |
| NIH Device Record Key | 983074d0-71a8-4d22-b4a3-e6444d9338ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioStamp nPoint™ |
| Version Model Number | MC-0012 |
| Company DUNS | 840371087 |
| Company Name | Medidata Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B493MC0012 [Previous] |
| HIBCC | G012MC0012 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173510
FDA Product Code
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-09 |
| Device Publish Date | 2021-04-01 |
On-Brand Devices [BioStamp nPoint™]
| G012SW0028 | Web application |
| G012SW0027 | Investigator application for Android |
| G012SW0026 | Sync application for Android |
| G012SW0025 | Link application for Android |
| G012MC0015 | MC-0015 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 |
| G012MC0014 | MC-0014 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA0 |
| G012MC0013 | MC-0013 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 |
| G012MC0012 | MC-0012 kit containing DIs G012BRCS02, G012BRCD02, BG012BRCP03, G012BSPS01, G012BRCA05 |
| G012MC0008 | MC-0008 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 |
| G012MC0007 | MC-0007 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA0 |
| G012MC0006 | MC-0006 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 |
| G012MC0005 | MC-0005 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 |
| G012MC0004 | Discovery Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G012BRCP03, G012BRC |
| G012MC0003 | Exploratory Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G012BRCP03, G012B |
| G012BRCT01 | Mobile Application tablet |
| G012BRCP01 | Mobile application phone |
Trademark Results [BioStamp nPoint]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSTAMP NPOINT 87446310 5460543 Live/Registered |
MC10, Inc. 2017-05-11 |
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