Aqueduct SED

GUDID ACCCARTV101

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for mon

AQUEDUCT CRITICAL CARE, INC.

Cerebrospinal fluid pressure regulation system sensor/tubing set
Primary Device IDACCCARTV101
NIH Device Record Key935731c2-3709-40d5-9cc7-f7b2ed277911
Commercial Distribution StatusIn Commercial Distribution
Brand NameAqueduct SED
Version Model NumberACC-CART-101V
Company DUNS089176922
Company NameAQUEDUCT CRITICAL CARE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 24 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCACCCARTV101 [Primary]

FDA Product Code

JXGShunt, Central Nervous System And Components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-02
Device Publish Date2018-04-01

On-Brand Devices [Aqueduct SED]

ACCKIT101The Aqueduct Smart External Drain Kit is a convenience kit of the re-usable portions of the Aque
ACCCON101The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial press
ACCCART101The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interf
ACCKIT200The Aqueduct Smart External Drain Kit is a convenience kit of the re-usable portions of the Aque
ACCCONS200The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial press
ACCCARTV101The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interf
ACCCARTL200The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interf
ACCKIT100The Aqueduct Smart External Drain Kit is a convenience kit of the re-usable portions of the Aque
ACCCON100The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial press
ACCCART100The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interf
ACCBAG100The Aqueduct SED Drain Bag interfaces with the Aqueduct SED Cartridge to collect CSF.
ACCHLD100The Aqueduct SED Drain Bag Holder interfaces with the Aqueduct SED Drain Bag (ACCBAG000) when in

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