FDA.reportPublic FDA data

CAPIOX

Primary DI
54987350743256
Brand
CAPIOX
Company
TERUMO CORPORATION
Model
ZZ*CP50A
Catalog number
ZZ*CP50A
Device description
CAPIOX CARDIOPLEGIA
Published
2024-05-20
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350743256PackageGS120In Commercial Distribution
04987350743251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735074325654987350743256
04987350743251049873507432514987350743251

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system heat exchanger, single-useA device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typically be a module of a cardiopulmonary bypass system whereby it receives thermal transfer fluid at a specific temperature from a system heating/cooling unit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00AVOID DIRECT SUNLIGHT.
Special Storage Condition, Specify00DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Storage Environment Temperature1 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)521-2818cvscustomerservice@terumomedical.com

Regulatory Flags#

DUNS number
690543319
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350700025OPTITORQUE40-5011RH*5TIG110A2016-09-09
04987350700049OPTITORQUE40-5012RH*5TIG210A2016-09-09
04987350700063OPTITORQUE40-5021RH*5BL3520A2016-09-09
04987350700087OPTITORQUE40-5022RH*5BL4020A2016-09-09
04987350700100OPTITORQUE40-5030RH*5SP0061A2016-09-09
04987350700124OPTITORQUE40-5031RH*5AP5561A2016-09-09
04987350700148OPTITORQUE40-5040RH*5SL3500A2016-09-09
04987350700162OPTITORQUE40-5041RH*5SL4000A2016-09-09
04987350700186OPTITORQUE40-5042RH*5SL5000A2016-09-09
04987350700209OPTITORQUE40-5043RH*5JR3500A2016-09-09
04987350700223OPTITORQUE40-5044RH*5JR4000A2016-09-09
04987350700247OPTITORQUE40-5045RH*5JR5000A2016-09-09
04987350700261OPTITORQUE40-5050RH*5BPIR00A2016-09-09
04987350700285OPTITORQUE40-5060RH*5SAL100A2016-09-09
04987350700308OPTITORQUE40-5061RH*5SAL200A2016-09-09
04987350700322OPTITORQUE40-6011RH*6TIG110A2016-09-09
04987350700346OPTITORQUE40-6012RH*6TIG210A2016-09-09
04987350700360OPTITORQUE40-6021RH*6BL3520A2016-09-09
04987350700384OPTITORQUE40-6022RH*6BL4020A2016-09-09
04987350700407OPTITORQUE40-6030RH*6SP0061A2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054117372446TRILLYEUROSETS SRLDTR2026-05-05
08054117372545HORIZONEUROSETS SRLDTR2026-05-05
18051160302212Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSPECTRUM MEDICAL SRLDTR2026-03-18
05060434420831QuantumSPECTRUM MEDICAL LIMITEDDTR2026-02-27
18051160302236Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 WSPECTRUM MEDICAL SRLDTR2025-12-23
18051160302274Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 WSPECTRUM MEDICAL SRLDTR2025-12-23
08033178114288VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114479VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114486VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
05060912587483CMO8 Adult PMP Oxygenator with Tubing PackCHALICE MEDICAL LIMITEDDTR2025-02-07
18051160302205Quantum PureFlow Standard Heat Exchanger High Flow 3/8 WSPECTRUM MEDICAL SRLDTR2024-11-19
18051160302267Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 WSPECTRUM MEDICAL SRLDTR2024-11-19
05060491619810CMO8 Adult PMP Oxygenator with Tubing PackCHALICE MEDICAL LIMITEDDTR2024-10-07
04987350743251CAPIOXTERUMO CORPORATIONDTR2024-05-20
08033178112840KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
08033178112864KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
08033178113465KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
08033178113472KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
38033178113466KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
05060491614129Adult Tubing Pack with Paragon Adult Maxi PMP OxygenatorCHALICE MEDICAL LIMITEDDTR2023-11-07
20634624530380MPS 3 ISO Medical Air Hose KitQUEST MEDICAL INCDTR2023-10-16
05415067036414CentriMag™Thoratec CorporationDTR2023-05-17
18051160302168Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 MSPECTRUM MEDICAL SRLDTR2023-05-04
18051160302175Quantum PureFlow Standard Heat Exchanger High Flow 3/8 MSPECTRUM MEDICAL SRLDTR2023-05-04
20634624530397MPS 3 Drug Pump CoverQUEST MEDICAL INCDTR2023-03-24
08051160301003Quantum PureFlow Standard Heat Exchanger Medium Flow 3/8SPECTRUM MEDICAL SRLDTR2022-05-30
08051160301171Quantum PureFlow Standard Heat Exchanger High Flow 3/8SPECTRUM MEDICAL SRLDTR2022-02-16
08051160301188Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4SPECTRUM MEDICAL SRLDTR2022-02-16
08051160301195Quantum PureFlow Standard Heat Exchanger Low Flow 3/16SPECTRUM MEDICAL SRLDTR2022-02-16
08051160301201Quantum PureFlow Standard Heat Exchanger Low Flow 1/4SPECTRUM MEDICAL SRLDTR2022-02-16