Braincare
GUDID 07908398200237
Headband 2 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| Primary Device ID | 07908398200237 |
| NIH Device Record Key | 1e083f81-226f-43d9-8770-e7489ae06c2a |
| 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 | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 Millimeter |
| Length | 540 Millimeter |
| Width | 20 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 | 07908398200237 [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 |
| 07908398200299 | Suitcase of Braincare Wireless Non-Invasive Intracranial Pressure and Brain Compliance Monitorin |
| 07908398200282 | Sensor Charger of Braincare Wireless Non-Invasive Intracranial Pressure and Brain Compliance Mon |
| 07908398200275 | Headband of Braincare Wireless Non-Invasive Intracranial Pressure and Brain Compliance Monitorin |
| 07908398200268 | Wireless Sensor of Braincare Wireless Non-Invasive Intracranial Pressure and Brain Compliance Mo |
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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