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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, gravity-flow FDA UDI
Device Name
The Aqueduct Smart External Drain Kit is a convenience kit of the re-usable portions of the Aqueduct SED System. The Aqueduct SED system is a collection of devices for Monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles. This kit contains ACCCON100 and ACCHLD100. FDA UDI
Model / Reference
ACC-KIT-100 FDA UDI
Description
The Aqueduct Smart External Drain Kit is a convenience kit of the re-usable portions of the Aqueduct SED System. The Aqueduct SED system is a collection of devices for Monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles. This kit contains ACCCON100 and ACCHLD100. FDA UDI

Identifiers

Catalog Number
ACC-KIT-100 FDA UDI
Primary DI / UDI-DI
ACCKIT100 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

Yes

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
MRI Safety
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

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Manufacturer

Manufacturer
Aqueduct Critical Care, Inc.

Sources (1)

  • FDA UDI 88ffaf1d-c5f0-4f76-9ba0-63c6f191e7f7 36 fields · synced Jun 1, 2026