FDA.report

CDI OneView™ Monitoring System

Primary DI
00886799002018
Brand
CDI OneView™ Monitoring System
Company
Terumo Cardiovascular Systems Corporation
Model
CDI782
Catalog number
CDI782
Device description
BPM Mounting Arm Bracket
Published
2024-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Product Code Classifications

CodeDeviceSpecialtyClass
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary BypassCardiovascular2

Premarket Submissions

SubmissionSupplement
K234065000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K234065000CDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation2024-04-25DRY

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00886799002018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799002018008867990020188867990020180886799002018

GMDN Terms

TermDefinition
Portable active medical device mountA device intended to be fixed (e.g., to a healthcare facility wall, ambulance, trolley, floor) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
177655466
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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50699753537106Cardiovascular Procedure Kit786012026-02-16
50699753537113Cardiovascular Procedure Kit786022026-02-16

Other Devices Sharing Product Codes

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
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
10886799001872CDI 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