FDA.reportPublic FDA data

CDI OneView™ Monitoring System

Primary DI
10886799001872
Brand
CDI OneView™ Monitoring System
Company
Terumo Cardiovascular Systems Corporation
Model
CDI747
Catalog number
CDI747
Device description
CDI OneView™ Calibration Gas 2
Published
2024-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234065000CDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation2024-04-25DRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886799001872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088679900187210886799001872

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system blood tubing setA collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature64.4 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177655466
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699753537880Cardiovascular Procedure Kit788312026-08-26
00699753537897Cardiovascular Procedure Kit788332026-08-26
00699753537903Cardiovascular Procedure KitCX-CZ226X2026-08-26
00699753537910Cardiovascular Procedure KitCX-UK7672026-08-26
00699753537927Cardiovascular Procedure KitCX-UK7682026-08-26
00699753537934Cardiovascular Procedure KitCX-UK7692026-08-26
00699753537941Cardiovascular Procedure KitCX-UK770X2026-08-26
00699753537958Cardiovascular Procedure KitCX-UK7712026-08-26
00699753537866Cardiovascular Procedure Kit75643-052026-08-21
00699753537873Cardiovascular Procedure Kit787982026-08-21
00699753537811Cardiovascular Procedure KitCX-PL1642026-08-17
00699753537828Cardiovascular Procedure KitCX-PL1652026-08-17
00699753537743Cardiovascular Procedure Kit788052026-08-03
00699753537750Cardiovascular Procedure Kit788122026-08-03
00699753537767Cardiovascular Procedure Kit786712026-08-03
00699753530638Cardiovascular Procedure Kit75972-022024-02-22
00699753532625Cardiovascular Procedure Kit783422024-08-09
00699753532311Cardiovascular Procedure Kit74737-022024-07-22
00699753532083Cardiovascular Procedure Kit77746-012024-07-09
00699753531734Cardiovascular Procedure Kit76373-022024-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886799001882CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001899CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001905CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001912CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001929CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001936CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001943CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001950CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001967CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001974CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001981CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799001998CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799002001CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799002018CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799002025CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799002032CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
00886799002049CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
10886799001865CDI OneView™ Monitoring System Terumo Cardiovascular Systems CorporationDRY2024-07-23
05060434422279QuantumSPECTRUM MEDICAL LIMITEDDRY2023-04-10
05060434422521QuantumSPECTRUM MEDICAL LIMITEDDRY2023-04-10
05060434422989QuantumSPECTRUM MEDICAL LIMITEDDRY2023-04-10
05060434422996QuantumSPECTRUM MEDICAL LIMITEDDRY2023-04-10
05060434423009QuantumSPECTRUM MEDICAL LIMITEDDRY2023-04-10
05060434423016QuantumSPECTRUM MEDICAL LIMITEDDRY2023-04-10
05060434423283QuantumSPECTRUM MEDICAL LIMITEDDRY2022-10-17
05060434423290QuantumSPECTRUM MEDICAL LIMITEDDRY2022-10-17
05060434423306QuantumSPECTRUM MEDICAL LIMITEDDRY2022-10-17
05060434422293QuantumSPECTRUM MEDICAL LIMITEDDRY2022-01-12
04037691447445BMU 40Maquet Cardiopulmonary AGDRY2021-09-30
04037691467207BMU 40Maquet Cardiopulmonary AGDRY2021-09-30