FDA.reportPublic FDA data

CardioQuip Standard Hose Set 6' with Staight HX

Primary DI
00850054036452
Brand
CardioQuip Standard Hose Set 6' with Staight HX
Company
CARDIOQUIP, LLC
Model
MCH-11SHS-SHX
Published
2025-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWCController, Temperature, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWCController, Temperature, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102147000CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp2010-11-19DWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054036452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054036452008500540364528500540364520850054036452

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system heating/cooling unitA mains electricity (AC-powered) component of a cardiopulmonary bypass system designed to heat or cool a patient's body by extracorporeal heat exchange with the patient's perfused blood during a cardiopulmonary bypass procedure. It consists of a system to heat or cool a thermal transfer fluid, pumps to provide circulation of the fluid to a heat exchanger, and monitoring and alarm systems. It may be known as a hypothermia/hyperthermia unit because of its ability to regulate body temperature either way.

Regulatory Flags#

DUNS number
144183733
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054036629Cardio Quip VivaCart Short Infusion Pole with Removable HooksVC-C-INFS2025-10-28
00850054036254CardioQuip Dripless Hose Set 10' with 90 ConnectorsMCH-10D902025-10-27
00850054036261CardioQuip Dripless Hose Set 10' 90 Connectors and Straight HXMCH-10D90-SHX2025-10-27
00850054036278CardioQuip Dripless Hose Set 10'MCH-10DAM2025-10-27
00850054036285CardioQuip Dripless Hose Set 10' with Straight HXMCH-10DAM-SHX2025-10-27
00850054036292CardioQuip Dripless Hose Set 10' with Blanket AdapterMCH-10DMB2025-10-27
00850054036308CardioQuip Dripless Hose Set 10' with Blanket Adapter and Straight HXMCH-10DMB-SHX2025-10-27
00850054036315CardioQuip Dripless End SetMCH-10DRP2025-10-27
00850054036322CardioQuip Dripless End Set with Straight HXMCH-10DRP-SHX2025-10-27
00850054036339"CardioQuip Oxygenator Connector, Right Angle, 1/2"" Hose Barb"MCH-10HRB2025-10-27
00850054036346"CardioQuip Oxygenator Connector. Straight, 1/2"" Hose Barb"MCH-10HSB2025-10-27
00850054036353"CardioQuip Main/CPG Connector. Male. Right Angle, 1/2"" Hose Barb"MCH-10MRB2025-10-27
00850054036360CardioQuip Standard Hose Set 10' with 90 ConnectorsMCH-10S902025-10-27
00850054036377CardioQuip Standard Hose Set 10' with 90 Connectors and Staight HXMCH-10S90-SHX2025-10-27
00850054036384CardioQuip Standard Hose Set 10' with Blanket AdapterMCH-10SHB2025-10-27
00850054036391CardioQuip Standard Hose Set 10' with Blanket Adapter and Straight HXMCH-10SHB-SHX2025-10-27
00850054036407CardioQuip Standard Hose Set 10'MCH-10SHS2025-10-27
00850054036414CardioQuip Standard Hose Set 10' with Straight HXMCH-10SHS-SHX2025-10-27
00850054036421CardioQuip Dripless Hose Set 6'MCH-11DAM2025-10-27
00850054036438CardioQuip Dripless Hose Set 6' with Straight HXMCH-11DAM-SHX2025-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054036254CardioQuip Dripless Hose Set 10' with 90 ConnectorsCARDIOQUIP, LLCDWC2025-10-27
00850054036261CardioQuip Dripless Hose Set 10' 90 Connectors and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036278CardioQuip Dripless Hose Set 10'CARDIOQUIP, LLCDWC2025-10-27
00850054036285CardioQuip Dripless Hose Set 10' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036292CardioQuip Dripless Hose Set 10' with Blanket AdapterCARDIOQUIP, LLCDWC2025-10-27
00850054036308CardioQuip Dripless Hose Set 10' with Blanket Adapter and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036315CardioQuip Dripless End SetCARDIOQUIP, LLCDWC2025-10-27
00850054036322CardioQuip Dripless End Set with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036339"CardioQuip Oxygenator Connector, Right Angle, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036346"CardioQuip Oxygenator Connector. Straight, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036353"CardioQuip Main/CPG Connector. Male. Right Angle, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036360CardioQuip Standard Hose Set 10' with 90 ConnectorsCARDIOQUIP, LLCDWC2025-10-27
00850054036377CardioQuip Standard Hose Set 10' with 90 Connectors and Staight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036384CardioQuip Standard Hose Set 10' with Blanket AdapterCARDIOQUIP, LLCDWC2025-10-27
00850054036391CardioQuip Standard Hose Set 10' with Blanket Adapter and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036407CardioQuip Standard Hose Set 10'CARDIOQUIP, LLCDWC2025-10-27
00850054036414CardioQuip Standard Hose Set 10' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036421CardioQuip Dripless Hose Set 6'CARDIOQUIP, LLCDWC2025-10-27
00850054036438CardioQuip Dripless Hose Set 6' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036445CardioQuip Standard Hose Set 6'CARDIOQUIP, LLCDWC2025-10-27
00850054036605CardioQuip Mini wheel SetCARDIOQUIP, LLCDWC2025-10-27
05060434422460QuantumSPECTRUM MEDICAL LIMITEDDWC2022-10-25
05060434422477QuantumSPECTRUM MEDICAL LIMITEDDWC2022-10-25
05060434422484QuantumSPECTRUM MEDICAL LIMITEDDWC2022-10-25
05060434422491QuantumSPECTRUM MEDICAL LIMITEDDWC2022-10-25
05060434423757QuantumSPECTRUM MEDICAL LIMITEDDWC2022-06-09
05060434420961QuantumSPECTRUM MEDICAL LIMITEDDWC2022-05-18
00860000846103CardioQuip Modular Cooler-Heater (MCH)CARDIOQUIP, LLCDWC2020-12-08
00860000846110CardioQuip Modular Cooler-Heater (MCH)CARDIOQUIP, LLCDWC2020-12-08
00860000846127CardioQuip Refrigeration ModuleCARDIOQUIP, LLCDWC2020-12-08