Opal DataHub ODHV2C
GUDID 00850023837042
The Opal DataHub is an accessory that extracts raw sensor data from the Opal V2C sensors and uploads it to a remote server where the files are processed. Additionally, the Opal DataHub recharges the battery of the Opal V2C sensors.
ERESEARCHTECHNOLOGY, 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| Primary Device ID | 00850023837042 |
| NIH Device Record Key | a5c0523b-b500-48a9-9a16-004dca1340c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Opal DataHub |
| Version Model Number | V2C |
| Catalog Number | ODHV2C |
| Company DUNS | 867288557 |
| Company Name | ERESEARCHTECHNOLOGY, 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com | |
| Phone | 8007049698 |
| customercare@ert.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850023837042 [Primary] |
FDA Product Code
| ISD | Exerciser, Measuring |
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 | 2021-04-08 |
| Device Publish Date | 2021-03-31 |
Devices Manufactured by ERESEARCHTECHNOLOGY, INC.
| 00850023837042 - Opal DataHub | 2021-04-08The Opal DataHub is an accessory that extracts raw sensor data from the Opal V2C sensors and uploads it to a remote server where the files are processed. Additionally, the Opal DataHub recharges the battery of the Opal V2C sensors. |
| 00850023837042 - Opal DataHub | 2021-04-08 The Opal DataHub is an accessory that extracts raw sensor data from the Opal V2C sensors and uploads it to a remote server where |
| 00850023837011 - Opal V2C | 2021-01-26 Opal V2C is a small Worn Monitor designed for documenting physical movement associated with applications in physiological monito |
| 00850023837028 - Docking Station V2C | 2021-01-26 Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Dock |
| 00850023837035 - Access Point V2C | 2021-01-26 Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C. |
| 08500238370019 - Opal V2C | 2020-10-01 Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monito |
| 08500238370026 - Docking Station V2C | 2020-10-01 Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Dock |
| 08500238370033 - Access Point V2C | 2020-10-01 Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C. |
Trademark Results [Opal DataHub]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPAL DATAHUB 90599546 not registered Live/Pending |
eResearchTechnology, Inc. 2021-03-24 |
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