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| 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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