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
00699753532731Cardiovascular Procedure Kit75959-022024-08-23
00699753532663Cardiovascular Procedure Kit73346-022024-08-20
00699753532250Cardiovascular Procedure Kit75197-012024-07-19
00699753531666Cardiovascular Procedure Kit74100-032024-06-04
00699753531345Cardiovascular Procedure Kit77087-012024-05-09
00699753531017Cardiovascular Procedure Kit65167-072024-03-21
00699753537439Cardiovascular Procedure KitCX-SV1272026-05-15
00699753537446Cardiovascular Procedure KitCX-SV1292026-05-15
00699753537453Cardiovascular Procedure Kit787752026-05-15
00812763011007OPUSWAVE01000-002026-05-13
00699753537378Cardiovascular Procedure KitCX-CZ2172026-05-05
00699753537361Cardiovascular Procedure KitCX-GE468X2026-05-04
00699753537385Cardiovascular Procedure KitCX-IS1272026-05-04
00699753537392Cardiovascular Procedure KitCX-SV1262026-05-04
00699753537408Cardiovascular Procedure KitCX-SV1282026-05-04
00699753537415Cardiovascular Procedure Kit780832026-05-04
00699753537422Cardiovascular Procedure Kit786492026-05-04
00699753532601Cardiovascular Procedure Kit74121-032024-08-08
00699753531406Cardiovascular Procedure Kit75472-012024-05-10
00699753531420Cardiovascular Procedure Kit75140-012024-05-10

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