Home GUDID 00860001797916 Abiomed Breethe OXY-1 System
Primary DI 00860001797916
Brand Abiomed Breethe OXY-1 System
Company Breethe, Inc.
Model 1000140
Catalog number 001-0400-100
Device description Abiomed Breethe OXY-1 PLU Disposable
Published 2020-11-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use 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 00860001797916 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860001797916 00860001797916 860001797916 0860001797916
GMDN Terms# Term, Definition table Term Definition Extracorporeal membrane oxygenator A device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.
Regulatory Flags# DUNS number 079455574 Device count 1 Kit true Serial number true Expiration 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 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 00813502012361 Abiomed Breethe OXY-1 System 001-3300-039 001-3300-039 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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