Product Code: DTZ


Products Classified as DTZ

799Oxygenator, Cardiopulmonary BypassCardiopulmonary Bypass Oxygenator.

Total Product Life Cycle (TPLC) Devices

799Oxygenator, Cardiopulmonary BypassCardiopulmonary Bypass Oxygenator.

FDA Consensus Standards

Oxygenator, Cardiopulmonary Bypass [36828]21 CFR §870.4350 🔎

Pre-market Notifications for DTZ

K222297CentriMag Pre-connected PackAbbott
K212341Quantum Perfusion Blood Oxygenator With Integrated AF And Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator With Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator With Integrated AF And Sensor VT160-C1U,Quantum Perfusion Blood OxygenatorQura S.r.l.
K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2Qura S.r.l.
K203111Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation SystemMedtronic
K202510AMG PMP InfantEurosets S.r.l.
K202206AMG PMP PediatricEurosets S.r.l.
K201916Inspire 6M Hollow Fiber Oxygenator, Inspire 7M Hollow Fiber Oxygenator, Inspire 8M Hollow Fiber OxygenatorSorin Group Italia S.r.l
K201642Paragon Adult Maxi PMP Oxygenator With Tubing PackChalice Medical Ltd
K200683INSPIRE 7FM Hollow Fiber Oxygenator With Integrated Arterial Filter, INSPIRE 7F Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Reservoir, INSPIRE 7F DUAL Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell ResSorin Group Italia S.R.L.
K200109OXY-1 SystemAbiomed Inc.
K191444Affinity NT Oxygenator With Balance Biosurface, Affinity NT Oxygenator With Balance Biosurface And Uncoated Cardiotomy/Venous ReservoirMedtronic, Inc.
K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)Chalice Medical Ltd
K191029Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator With Plasma Resistant Fiber (PRF) With TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator With Plasma Resistant Fiber (Model 541), Affinity® NMedtronic, Inc.
K190690INSPIRE 7 Hollow Fiber Oxygenator With Integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator With Integrated Hardshell/Venous Cardiotomy ReservoirSORIN GROUP ITALIA S.R.L.
K183511Affinity Pixieâ„¢ Oxygenator With Balanceâ„¢ Biosurface (Model BBP211), Affinity Pixieâ„¢ Oxygenator And Cardiotomy/Venous Reservoir With Balanceâ„¢ Biosurface (Model BBP241), Affinity Pixieâ„¢ Oxygenator With Cortivaâ„¢ BioActive Surface (Model CBP211), AffinitMedtronic Inc

Global Unique Device Identification Database

00613994951311OXYGENATOR, CARDIOPULMONARY BYPASS
00613994951304OXYGENATOR, CARDIOPULMONARY BYPASS
20613994947172OXYGENATOR, CARDIOPULMONARY BYPASS
00613994937889OXYGENATOR, CARDIOPULMONARY BYPASS
20613994937869OXYGENATOR, CARDIOPULMONARY BYPASS
00613994933775OXYGENATOR, CARDIOPULMONARY BYPASS
00613994930316OXYGENATOR, CARDIOPULMONARY BYPASS
00613994929532OXYGENATOR, CARDIOPULMONARY BYPASS
20613994926719OXYGENATOR, CARDIOPULMONARY BYPASS
00613994923264OXYGENATOR, CARDIOPULMONARY BYPASS
00613994923202OXYGENATOR, CARDIOPULMONARY BYPASS
00613994923196OXYGENATOR, CARDIOPULMONARY BYPASS
00613994920249OXYGENATOR, CARDIOPULMONARY BYPASS
20613994917731OXYGENATOR, CARDIOPULMONARY BYPASS
20613994915010OXYGENATOR, CARDIOPULMONARY BYPASS

Maude Adverse Events

CAPIOX FX05TERUMO CORPORATION, ASHITAKA2020-03-31
HLS SET ADVANCED 7.0 WITH BIOLINE COATINGMAQUET CARDIOPULMONARY GMBH2020-03-30
CAPIOX FX OXYGENATORTERUMO CORPORATION, ASHITAKA2020-03-25
CAPIOX RX25 OXYGENATOR EASTTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-23
NS RX15RW OX W 4L RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-17
STERILE FX25REC W/RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-17
OXYGENATORSMAQUET CARDIOPULMONARY GMBH2020-03-14
OXYGENATORSMAQUET CARDIOPULMONARY GMBH2020-03-14
NS FX25REC W/RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-12
STERILE FX25REC W/RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-11
HLM TUBING SET W/BIOLINE COATINGMAQUET CARDIOPULMONARY GMBH2020-03-11
HLM TUBING SET W/BIOLINE COATINGMAQUET CARDIOPULMONARY GMBH2020-03-11
STERILE FX25RWC W/ RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-10
STERILE FX25REC W/RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-10
STERILE FX15RWC W/ 3L RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-10
FUSION HOLLOW FIBER OXYGENATORPERFUSION SYSTEMS2020-03-10
LIVA NOVA SORIN 6F INSPIRE OXYGENATORLIVA NOVA SORIN / LIVA NOVA USA, INC.2020-03-06
CAPIOX FX OXYGENATORTERUMO CORPORATION, ASHITAKA2020-03-06
CAPIOX FX25 OXYGENATORTERUMO CORPORATION, ASHITAKA2020-03-06
OXYGENATORSMAQUET CARDIOPULMONARY GMBH2020-03-04
AFFINITY OXY NT 511PERFUSION SYSTEMS2020-03-04
CAPIOX FX OXYGENATORTERUMO CORPORATION, ASHITAKA2020-03-04
STERILE FX25RWC W/ RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-03
STERILE FX25REC W/RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-03
CAPIOX FX25 OXYGENATORTERUMO CORPORATION, ASHITAKA2020-03-03
NS FX25REC W/RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-02
STERILE FX25RWC W/ RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-02
CAPIOX RX25 OXYGENATOR EASTTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-02
SHUNT SENSOR SYS500TERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-02
HLM TUBING SET W/BIOLINE COATINGMAQUET CARDIOPULMONARY GMBH2020-03-02
NS FX15RWC W/3L RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-02-28
CAPIOX FX25 OXYGENATORTERUMO CORPORATION, ASHITAKA2020-02-28
CAPIOX FX OXYGENATORTERUMO CORPORATION, ASHITAKA2020-02-28
SMART PERFUSION PACKLIVANOVA USA, INC2020-02-27
CAPIOX FX25 OXYGENATORTERUMO CORPORATION, ASHITAKA2020-02-27
CAPIOX FX OXYGENATORTERUMO CORPORATION, ASHITAKA2020-02-26
STERILE FX25REC W/RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-02-25
STERILE FX25RWC W/ RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-02-25
OXYGENATORSMAQUET CARDIOPULMONARY GMBH2020-02-25
CAPIOX FX OXYGENATORTERUMO CORPORATION, ASHITAKA2020-02-25
HLM TUBING SET W/BIOLINE COATINGMAQUET CARDIOPULMONARY GMBH2020-02-25
HLM TUBING SET W/BIOLINE COATINGMAQUET CARDIOPULMONARY GMBH2020-02-24
HLM TUBING SET W/BIOLINE COATINGMAQUET CARDIOPULMONARY GMBH2020-02-22
HLS SET ADVANCED 7.0 WITH BIOLINE COATINGMAQUET CARDIOPULMONARY GMBH2020-02-20
HLM TUBING SET W/BIOLINE COATINGMAQUET CARDIOPULMONARY GMBH2020-02-20
CAPIOX FX25 OXYGENATORTERUMO CORPORATION, ASHITAKA2020-02-20
STERILE NX19RE W/ 4L RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-02-18
STERILE FX25RWC W/ RESTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-02-18
HLS SET ADVANCED 7.0 WITH BIOLINE COATING2020-02-17
HLM TUBING SET W/BIOLINE COATINGMAQUET CARDIOPULMONARY GMBH2020-02-17
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