FDA.report

ShuntCheck III DAQ

Primary DI
00865435000328
Brand
ShuntCheck III DAQ
Company
NEURODX DEVELOPMENT LLC
Model
DAQ-1
Catalog number
DAQ-1
Device description
Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor
Published
2018-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JXGShunt, Central Nervous System And Components

Product Code Classifications

CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions

SubmissionSupplement
K123554000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K123554000SHUNTCHECKNeurodx Development, LLC2013-03-07JXG

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00865435000328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00865435000328008654350003288654350003280865435000328

GMDN Terms

TermDefinition
Heater/cooler system tester kitA collection of devices intended to be used to test/calibrate a clinical heater/cooler system (e.g., extravascular-circulation hyperthermia system, heating/cooling pad systems) with respect to fluid flow, thermal calibration, and electronic integrity. The kit may include a pressure/flow calibration unit, a thermocouple thermometer, a breakout box and relevant connection cables. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.

Sterilization Methods

Method

Regulatory Flags

DUNS number
828682240
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00865435000311ShuntCheck III SoftwareSCIII SWSCIII SW2018-10-18
00865435000335ShuntCheck Test PackTP-1TP-12018-10-18

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