Identity
- Trade Name
- Aqueduct SED FDA UDI
- Generic Name
- Cerebrospinal fluid pressure regulation system, gravity-flow FDA UDI
- Device Name
- The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles. FDA UDI
- Model / Reference
- ACC-CON-100 FDA UDI
- Description
- The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- ACCCON100 FDA UDI
- 510(k) Number
- K161605 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Cerebrospinal fluid pressure regulation system, gravity-flow FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Aqueduct SED by Aqueduct Critical Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K161605 also covers:
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
- Aqueduct Critical Care, Inc.
Sources (1)
- FDA UDI 11a5bb11-cace-462a-a6ce-4d7796b7cf89 36 fields · synced Jun 6, 2026