FDA.reportPublic FDA data

Capiox® Flexible Venous Reservoir

Primary DI
50699753450191
Brand
Capiox® Flexible Venous Reservoir
Company
Terumo Cardiovascular Systems Corporation
Model
3CXFVR1500X
Published
2016-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTNReservoir, Blood, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070839000MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIRTerumo Cardiovascular Systems Corp.2007-04-24DTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753450191PackageGS15In Commercial Distribution
00699753450196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975345019150699753450191
00699753450196006997534501966997534501960699753450196

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotomy reservoirA device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.

Sterilization Methods#

Method table
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
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
00699753537460Cardiovascular Procedure KitCX-DB080-012026-06-02
00699753537477Cardiovascular Procedure Kit787792026-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054117372446TRILLYEUROSETS SRLDTN2026-05-05
08054117372545HORIZONEUROSETS SRLDTN2026-05-05
08033178113144INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178113151INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
38033178113145INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
38033178113152INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178113717XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113748XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113755XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113762XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113922XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113960XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113977XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113991XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114004XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114011XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114028XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114035XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114042XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114059XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114066XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114073XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114080XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114097XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114103XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114110XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114127XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114134XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114141XTRASORIN GROUP ITALIA SRLDTN2024-12-20