FDA.reportPublic FDA data

OXY-1 System

Primary DI
10860001797968
Brand
OXY-1 System
Company
Breethe, Inc.
Model
001-3300-039
Catalog number
001-3300-039
Device description
Console Intake Filter, 5pk
Published
2020-12-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWAControl, Pump Speed, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWAControl, Pump Speed, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860001797968PrimaryGS10
00860001797961Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000179796810860001797968
00860001797961008600017979618600017979610860001797961

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system, non-roller typeAn 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 DIBrandModelCatalogPublished
00860001797916Abiomed Breethe OXY-1 System1000140001-0400-1002020-11-30
00813502013184Abiomed Breethe OXY-1 System200073520007352023-06-02
00813502013245Abiomed Breethe OXY-1 System300103030010302023-06-02
00860001797954Abiomed Breethe OXY-1 System001-0901-003001-0901-0032020-11-30
00813502012354Abiomed Breethe OXY-1 System001-0403-006001-0403-0062023-05-26
00813502012361Abiomed Breethe OXY-1 System001-3300-039001-3300-0392023-05-26
10860001797920Abiomed Breethe OXY-1 System001-0403-004001-0403-0042020-12-02
00860001797985Abiomed Breethe OXY-1 System001-0403-008001-0403-0082023-05-26
00860001797909Abiomed Breethe OXY-1 System001-0500-001001-0500-0012020-11-30
00860001797930Abiomed Breethe OXY-1 System001-3300-0011001-3300-0112020-11-30
00860001797947Abiomed Breethe OXY-1 System001-0301-003001-0301-0032020-11-30
00860001797961OXY-1 SystemConsole Intake Filter, 5pk001-3300-0392020-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640135140153CentriMag™Thoratec CorporationDWA2026-02-19
00850000067141Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2025-08-26
07290117830055INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830062INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830093INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830147INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830048INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830052INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830069INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830086INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830090INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830109INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830116INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830144INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
00850000067059Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067066Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067073Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067080Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067097Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067103Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067110Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067127Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
04897102200065Anivia SG1000 Pump ConsoleAsia Pacific Medical Technology Development Company LimitedDWA2024-09-11
05415067036414CentriMag™Thoratec CorporationDWA2023-05-17
00763000301347NAMEDTRONIC, INC.DWA2023-03-18
00814112020586LifeSPARCCARDIACASSIST, INC.DWA2023-02-24
00814112020906LifeSPARCCARDIACASSIST, INC.DWA2022-05-10
04033817902782CP5LivaNova Deutschland GmbHDWA2021-05-14
00860001797961OXY-1 SystemBreethe, Inc.DWA2020-12-02
00860001797909Abiomed Breethe OXY-1 SystemBreethe, Inc.DWA2020-11-30