Identity
- Trade Name
- Aqueduct SED FDA UDI
- Generic Name
- Cerebrospinal fluid pressure regulation system sensor/tubing set FDA UDI
- Device Name
- The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for draining and monitoring of CSF flow from the lumbar region. FDA UDI
- Model / Reference
- ACC-CART-200L FDA UDI
- Description
- The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for draining and monitoring of CSF flow from the lumbar region. FDA UDI
Identifiers
- Primary DI / UDI-DI
- ACCCARTL200 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Cerebrospinal fluid pressure regulation system sensor/tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Cerebrospinal fluid pressure regulation system sensor/tubing set
Aqueduct SED by Aqueduct Critical Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cerebrospinal fluid pressure regulation system sensor/tubing set.
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- Drainage Set LiquoGuard 7 — Möller Medical GmbH · Class II
- Drainage Set LiquoGuard 7 — Möller Medical GmbH · Class II
- Drainage Set LiquoGuard 7 — Möller Medical GmbH · Class II
- Drainage Set LiquoGuard US — Möller Medical GmbH · Class II
- Aqueduct SED — Aqueduct Critical Care, Inc. · Class II
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 6f751567-652c-4136-b6bd-cdf1e127f00b 34 fields · synced May 30, 2026