Braincare
Both Headband Set of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcAc-AF-1000) and Headband Set of Braincare Wirelss Non-Invasive…
Both Headband Set of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcAc-AF-1000) and Headband Set of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcAc-FU-1000)
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Braincare Desenvolvimento E Inovacao Tecnologica SA |
|---|---|
| FDA product code | GWM |
| Device type | Device, Monitoring, Intracranial Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1620 |
| 510(k) | K240821 |
| Record published | 2024-08-28 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 15 to 85 % RH; Storage environment temperature 0 to 35 °C |
| Sizes | Width 17.5 to 275 mm; length 70 to 623 mm; height 14.7 to 385 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BcAc-AF-2000 | Length 352 mm | In distribution |
| BcAc-AF-1000 | Length 426 mm | In distribution |
| BcAc-AF-1000 | Length 546 mm | In distribution |
| BcAc-AF-1000 | Length 260 mm | In distribution |
| BcAc-FU-1000 | Length 623 mm | In distribution |
| BcAc-AF-1000 | Length 460 mm | In distribution |
| BcAc-AF-1000 + BcAc-FU-1000 | Width 40 mm | In distribution |
| BcAc-CASE-2000 | Length 331 mm | In distribution |
| BcAc-AF-1000 | Length 465 mm | In distribution |
| BcSs-PICNIW-2000 | Length 240 mm | In distribution |
| BcAc-AF-1000 | Height 385 mm | In distribution |
| BcAc-AF-1000 | Length 350 mm | In distribution |
| BcAc-AF-1000 | Length 320 mm | In distribution |
| BcSs-PICNIW-1000 | Length 75.6 mm | In distribution |
| BcAc-AF-1000 | Length 623 mm | In distribution |
| BcAc-AF-1000 | Length 502 mm | In distribution |
| BcAc-CASE-1000 | Length 335 mm | In distribution |
| BcAc-BATEX-1000 | Length 75.6 mm | In distribution |
| BcAc-AF-1000 | Length 540 mm | In distribution |
| BcAc-AF-1000 | Length 77 mm | In distribution |
| BcAc-DG-1000 | Length 94 mm | In distribution |
| BcAc-DCK-1000 | Length 75.6 mm | In distribution |
| BcAc-DCK-2000 | Length 86 mm | In distribution |
| BcSs-PICNI-2000 | Length 70 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Licox® | GMS, Gesellschaft für medizinische Sondentechnik mbH | 38 |
| Sophysa | Sophysa | 32 |
| Becker® | Medtronic PS Medical | 31 |
| Codman | Cerenovus, Inc. | 29 |
| Device, Monitoring, Intracranial Pressure | Medtronic PS Medical | 28 |
| Exacta™ | Medtronic PS Medical | 28 |
| Camino® | Integra Lifesciences (Ireland) Limited | 20 |
| Codman® | Integra LifeSciences Production Corporation | 19 |
| Integra® | Integra Lifesciences (Ireland) Limited | 17 |
| Aura | Branchpoint & Aura Development LLC | 17 |
| Natus | Natus Medical Incorporated | 15 |
| Duet® | Medtronic PS Medical | 14 |
Showing 12 of 133. All products under Device, Monitoring, Intracranial Pressure
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.