AURA
GUDID G460TK1010
AURA™ Monitor Pack
Branchpoint & Aura Development LLC
Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor| Primary Device ID | G460TK1010 |
| NIH Device Record Key | d7b9a19e-f3b9-462d-a565-03c225eda9bb |
| Commercial Distribution Discontinuation | 2024-02-28 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | AURA |
| Version Model Number | TK101 |
| Company DUNS | 063237649 |
| Company Name | Branchpoint & Aura Development LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 105 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G460TK1010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172209
FDA Product Code
| GWM | Device, Monitoring, Intracranial Pressure |
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 | 2024-02-29 |
| Device Publish Date | 2024-01-09 |
On-Brand Devices [AURA]
| G460TX1010 | AURA™ Monitor |
| G460TK1010 | AURA™ Monitor Pack |
| G460TC1010 | AURA™ Battery Charger |
| G460TB1010 | AURA™ Battery |
| G460TA1010 | AURA™ Antenna |
| G460SP1010 | AURA™ Sensor Tray |
| G460DG1010 | AURA™ Data Receiver Pack |
| 00860011785293 | AURA™ Holster |
| 00860011785286 | AURA™ Sensor & Holster |
| 00860011785279 | AURA™ Sensor |
| 00860011785262 | AURA™ Battery Charger |
| 00860011785255 | AURA™ Battery |
| 00860011785248 | AURA™ Antenna |
| 00860011785231 | AURA™ Monitor |
| 00860011785224 | AURA™ Data Receiver Pack |
| 00860011785217 | AURA™ Monitor Pack |
| 00860011785200 | AURA™ Sensor Tray |
Trademark Results [AURA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AURA 98508847 not registered Live/Pending |
Curant Health Georgia 2024-04-19 |
 AURA 98506483 not registered Live/Pending |
KHKA Playgrounds LLC 2024-04-18 |
 AURA 98439870 not registered Live/Pending |
Hearst Magazine Media, Inc. 2024-03-08 |
 AURA 98371991 not registered Live/Pending |
Rasheed Rasul 2024-01-23 |
 AURA 98302837 not registered Live/Pending |
College Park Industries, Inc. 2023-12-07 |
 AURA 98300508 not registered Live/Pending |
E. & J. Gallo Winery 2023-12-05 |
 AURA 98236498 not registered Live/Pending |
Spogen Biotech, Inc. 2023-10-23 |
 AURA 98236471 not registered Live/Pending |
Spogen Biotech, Inc. 2023-10-23 |
 AURA 98236370 not registered Live/Pending |
Spogen Biotech, Inc. 2023-10-23 |
 AURA 98235720 not registered Live/Pending |
Spogen Biotech, Inc. 2023-10-23 |
 AURA 98213624 not registered Live/Pending |
1 Beauty US LLC 2023-10-07 |
 AURA 98202246 not registered Live/Pending |
SUPPLE TEK INDUSTRIES PRIVATE LIMITED 2023-09-28 |
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