FDA.reportPublic FDA data

Affinity Fusion®

Primary DI
00643169178168
Brand
Affinity Fusion®
Company
MEDTRONIC, INC.
Model
BB811
Device description
OXYGENATOR BB811 FUSION W/BALANCE
Published
2015-06-17
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTZOXYGENATOR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTZOxygenator, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122827000
K203111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122827000AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811Medtronic, Inc.2012-12-14DTZ
K203111000Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation SystemMedtronic2021-09-16DTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169178168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169178168006431691781686431691781680643169178168

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal membrane oxygenatorA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974762681019LifemotionLifemotion Medical Technology Co., Ltd.DTZ2026-06-02
18051160300676Quantum Perfusion Blood Oxygenator VT200-E1SPECTRUM MEDICAL SRLDTZ2026-05-21
18051160300706Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2SPECTRUM MEDICAL SRLDTZ2026-05-21
18051160300768Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2SPECTRUM MEDICAL SRLDTZ2026-05-21
08054117372446TRILLYEUROSETS SRLDTZ2026-05-05
08054117372545HORIZONEUROSETS SRLDTZ2026-05-05
18051160302762Quantum Perfusion Blood Oxygenator VT200-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160302779Quantum Perfusion Blood Oxygenator VT160-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160303363Quantum Perfusion Blood Oxygenator VT75-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
08052705493351A.M.G.PMP PEDIATRIC EUROSETS SRLDTZ2025-02-19
08052705493368AMG PMP INFANT STERILE EUROSETS SRLDTZ2025-02-19
08033178112840KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178112864KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113465KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113472KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113342INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08033178113359INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08033178113366INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08052705496253A.M.G. PP SterileEUROSETS SRLDTZ2020-05-11
08033178113182INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08033178113212INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08033178113236INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08034013782020A.M.G. PMP SterileEUROSETS SRLDTZ2017-02-28
08033178250313RESERVOIRSORIN GROUP ITALIA SRLDTZ2016-09-15
00613994617309Affinity Pixie™MEDTRONIC, INC.DTZ2016-06-02
00643169178144Affinity Fusion®MEDTRONIC, INC.DTZ2016-05-02
00643169354869Affinity Fusion®MEDTRONIC, INC.DTZ2016-05-02
10887488435152CARDINAL HEALTHCardinal Health 200, LLCDTZ2016-01-27
08033178112758LILLIPUT PMPSORIN GROUP ITALIA SRLDTZ2015-11-25
00613994375636TRILLIUM® AFFINITY NT®MEDTRONIC, INC.DTZ2015-09-21