Braincare
GUDID 07908398200190
Headband Set of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcAc-AF-1000)
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
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 | 07908398200190 |
| NIH Device Record Key | e34c0d27-e87a-4b78-8f1a-a74a6419cf83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Braincare |
| Version Model Number | BcAc-AF-1000 |
| Company DUNS | 903226227 |
| Company Name | BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care | |
| Phone | +1 (424) 888-2942 |
| support@brain4.care |
Device Dimensions
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
| Length | 623 Millimeter |
| Width | 40 Millimeter |
| Height | 23.2 Millimeter |
Operating and Storage Conditions
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07908398200190 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201989
FDA Product Code
| GWM | Device, Monitoring, Intracranial Pressure |
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 | 2023-08-21 |
| Device Publish Date | 2023-08-11 |
On-Brand Devices [Braincare]
| 07908398200237 | Headband 2 of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitori |
| 07908398200220 | Headband 1 of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitori |
| 07908398200206 | Case of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring Sys |
| 07908398200190 | Headband Set of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monito |
| 07908398200183 | Turnbuckle of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitori |
| 07908398200176 | Headband XL of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitor |
| 07908398200169 | Headband L of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitori |
| 07908398200152 | Headband M of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitori |
| 07908398200145 | Headband S of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitori |
| 07908398200138 | Headband Childish XL of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Complianc |
| 07908398200121 | Headband Childish L of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance |
| 07908398200114 | Headband Childish M of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance |
| 07908398200107 | Headband Childish S of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance |
| 07908398200091 | Receiver Module Dongle of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Complia |
| 07908398200084 | External Baterry Charger of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compl |
| 07908398200077 | External Battery of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Mo |
| 07908398200060 | Wireless Sensor of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Mon |
| 07908398200251 | Both Headband Set of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance M |
| 07908398200244 | Headband Set of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monito |
Trademark Results [Braincare]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRAINCARE 98196125 not registered Live/Pending |
Priede, David 2023-09-25 |
 BRAINCARE 90630144 not registered Live/Pending |
Wave Neuroscience, Inc. 2021-04-07 |
 BRAINCARE 87567303 5521407 Live/Registered |
Nutrient Foods, LLC 2017-08-14 |
 BRAINCARE 87296553 not registered Dead/Abandoned |
Nutrient Foods, LLC 2017-01-11 |
 BRAINCARE 78017138 not registered Dead/Abandoned |
Brain.Com, Inc. 2000-07-17 |
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