Identity
- Trade Name
- Braincare FDA UDI
- Generic Name
- Intracranial pressure monitor FDA UDI
- Device Name
- Headband L of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcAc-AF-1000) FDA UDI
- Model / Reference
- BcAc-AF-1000 FDA UDI
- Description
- Headband L of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcAc-AF-1000) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07908398200169 FDA UDI
- 510(k) Number
- K201989 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Intracranial pressure monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 502 Millimeter FDA UDIWidth — 20 Millimeter FDA UDI
Category: Intracranial pressure monitor
Braincare by Braincare Desenvolvimento E Inovacao Tecnologica Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201989 also covers:
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
- Braincare — BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Braincare Desenvolvimento E Inovacao Tecnologica Sa
Sources (1)
- FDA UDI e5c06363-07f3-4c44-8cd6-11eb5f024361 37 fields · synced May 30, 2026