Kintinuum™
GUDID B493MC0011
MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05, B493MC0009
MC10, INC.
Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder Kinesiology ambulatory recorder 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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