FDA.report

ShuntCheck Test Pack

Primary DI
00865435000335
Brand
ShuntCheck Test Pack
Company
NEURODX DEVELOPMENT LLC
Model
TP-1
Catalog number
TP-1
Device description
ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pack and a skin marker in a clamshell container
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
true

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
10865435000318PackageGS110In Commercial Distribution
00865435000335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1086543500031810865435000318
00865435000335008654350003358654350003350865435000335

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
true
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
00865435000328ShuntCheck III DAQDAQ-1DAQ-12018-10-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00763000422646StrataMR2MEDTRONIC PS MEDICAL, INC.JXG2026-03-13
00763000422684StrataMR2MEDTRONIC PS MEDICAL, INC.JXG2026-03-13
03760409446294Phoenix NeuroSOPHYSAJXG2025-12-24
B775EVACMRI0PHASORPHASOR HEALTH LLCJXG2025-11-24
10381780521051CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535386CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535409CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535416CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535423CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535904CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535966CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535980CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536000CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536024CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536048CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536062CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536086CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536109CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
B775EVAC0PHASORPHASOR HEALTH LLCJXG2025-06-04
04041906505622XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906505639XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906505646XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506667XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506674XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506681XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506698XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506704XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506711XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506728XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506735XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31