Kintinuum™
GUDID B493MC0011
MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05, B493MC0009
MC10, INC.
Kinesiology ambulatory recorder| Primary Device ID | B493MC0011 |
| NIH Device Record Key | 4b7fcc20-971a-4c6c-9b18-2b14f9fb6d96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kintinuum™ |
| Version Model Number | MC-0011 |
| Company DUNS | 829221139 |
| Company Name | MC10, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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
| 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 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B493MC0011 [Primary] |
FDA Product Code
| ISD | Exerciser, Measuring |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2019-02-01 |
On-Brand Devices [Kintinuum™]
| B493SW0043 | Web application |
| B493SW0042 | Patient application for Android |
| B493MC0016 | Instructions for use |
| B493MC0011 | MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05, B493MC000 |
Trademark Results [Kintinuum]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KINTINUUM 87828840 not registered Live/Pending |
MC10, Inc. 2018-03-10 |
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