Home GUDID 00813502012361 Abiomed Breethe OXY-1 System
Primary DI 00813502012361
Brand Abiomed Breethe OXY-1 System
Company Breethe, Inc.
Model 001-3300-039
Catalog number 001-3300-039
Device description OXY-1 Console Intake Filter Qty 5
Published 2023-05-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name DTZ Oxygenator, Cardiopulmonary Bypass
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00813502012361 Primary GS1 0 00813502012712 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00813502012361 00813502012361 813502012361 0813502012361 00813502012712 00813502012712 813502012712 0813502012712
GMDN Terms# Term, Definition table Term Definition Cardiopulmonary bypass system, non-roller type An assembly of devices that provides mechanical circulatory support during open-heart surgery, bypassing the heart to facilitate surgery on the organ. The basic function of the machine is to oxygenate the body's venous supply of blood and then pump it back into the arterial circuit. It will typically provide features such as intracardiac suction, filtration, and temperature control. This device typically consists of mains electricity (AC-powered) console with centrifugal blood pumps, oxygenators, a heat exchanger, temperature regulators, a reservoir, filters, and a defoamer. Some systems are manufactured as a single unit while others are made up of modules.
Regulatory Flags# DUNS number 079455574 Device count 5 Lot or batch true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10860001797968 OXY-1 System 001-3300-039 001-3300-039 2020-12-02 00860001797916 Abiomed Breethe OXY-1 System 1000140 001-0400-100 2020-11-30 00813502013184 Abiomed Breethe OXY-1 System 2000735 2000735 2023-06-02 00813502013245 Abiomed Breethe OXY-1 System 3001030 3001030 2023-06-02 00860001797954 Abiomed Breethe OXY-1 System 001-0901-003 001-0901-003 2020-11-30 00813502012354 Abiomed Breethe OXY-1 System 001-0403-006 001-0403-006 2023-05-26 10860001797920 Abiomed Breethe OXY-1 System 001-0403-004 001-0403-004 2020-12-02 00860001797985 Abiomed Breethe OXY-1 System 001-0403-008 001-0403-008 2023-05-26 00860001797909 Abiomed Breethe OXY-1 System 001-0500-001 001-0500-001 2020-11-30 00860001797930 Abiomed Breethe OXY-1 System 001-3300-0011 001-3300-011 2020-11-30 00860001797947 Abiomed Breethe OXY-1 System 001-0301-003 001-0301-003 2020-11-30 00860001797961 OXY-1 System Console Intake Filter, 5pk 001-3300-039 2020-12-02
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