FDA.reportPublic FDA data

CardioQuip Standard Hose Set 10' with 90 Connectors and Staight HX

Primary DI
00850054036377
Brand
CardioQuip Standard Hose Set 10' with 90 Connectors and Staight HX
Company
CARDIOQUIP, LLC
Model
MCH-10S90-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
00850054036377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054036377008500540363778500540363770850054036377

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
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
00850054036445CardioQuip Standard Hose Set 6'MCH-11SHS2025-10-27

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
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
00850054036452CardioQuip Standard Hose Set 6' with Staight HXCARDIOQUIP, 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