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Aqueduct SED

FDA UDI

Class II (US FDA UDI)

by Aqueduct Critical Care, Inc.

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 (ACCCON100) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles. FDA UDI
Model / Reference
ACC-CART-100 FDA UDI
Description
The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON100) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles. FDA UDI

Identifiers

Primary DI / UDI-DI
ACCCART100 FDA UDI
510(k) Number
K161605 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
Not 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
MRI Safety
MR Conditional 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

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Manufacturer

Manufacturer
Aqueduct Critical Care, Inc.

Sources (1)

  • FDA UDI de11bb1b-f573-44c1-ae75-551c937f3de5 36 fields · synced May 31, 2026