BioStamp®
GUDID B493MC0009
Adhesive with hydrogel
MC10, INC.
Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software Biomechanical function analysis/rehabilitation software| Primary Device ID | B493MC0009 |
| NIH Device Record Key | 6b6414f4-e127-4284-a6b4-333a52604ecb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioStamp® |
| Version Model Number | BRCA02 |
| Company DUNS | 829221139 |
| Company Name | MC10, 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com | |
| Phone | 8572145630 |
| support@mc10inc.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| 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 | B493BRCA02 [Primary] |
| HIBCC | B493MC0009 [Package] Contains: B493BRCA02 Package: Box [42 Units] In Commercial Distribution |
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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2018-08-31 |
On-Brand Devices [BioStamp®]
| B493BSPS01 | Link Hub smart charger power supply |
| B493BRCS02 | Wearable sensor patch |
| B493BRCP03 | Mobile application phone |
| B493BRCD02 | Link Hub smart charger |
| B493BRCA05 | Adhesive applicator |
| B493MC0009 | Adhesive with hydrogel |
Trademark Results [BioStamp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSTAMP 86138311 4726162 Live/Registered |
MC10, Inc. 2013-12-09 |
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