FDA.reportPublic FDA data

Capiox® Hardshell Reservoir

Primary DI
00699753450394
Brand
Capiox® Hardshell Reservoir
Company
Terumo Cardiovascular Systems Corporation
Model
CX*CRXA
Published
2015-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DPWFlowmeter, Blood, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030505000CAPIOX CARDIOTOMY RESERVOIRTerumo Cardiovascular Systems Corp.2003-05-14DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753450399PackageGS14In Commercial Distribution
00699753450394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975345039950699753450399
00699753450394006997534503946997534503940699753450394

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.

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
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

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Primary DI, Brand, Company table
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00888937027839CooperSurgical® Coopersurgical, Inc.DPW2026-04-01
00813079022664VascuChek TransceiverREMINGTON MEDICAL, INC.DPW2025-11-27
00813079022671VascuChek Speaker DockREMINGTON MEDICAL, INC.DPW2025-11-27
00813079022688VascuChek KitREMINGTON MEDICAL, INC.DPW2025-11-27
00888937027822CooperSurgical® Coopersurgical, Inc.DPW2025-09-25
00627987360158Dual Adhesive Strap1929803 Ontario CorpDPW2025-06-23
10627987360155Dual Adhesive Strap1929803 Ontario CorpDPW2025-06-23
07070554102690Medistim MiraQ Vascular SystemMedistim ASADPW2024-08-25
07070554103611Medistim MiraQ Vascular SystemMedistim ASADPW2024-08-25
00813079022619VascuChek Surgical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022657VascuChek Clinical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
10813079022616VascuChek Surgical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022626VascuChek TransceiverREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022633VascuChek ChargerREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022640VascuChek KitREMINGTON MEDICAL, INC.DPW2024-08-23
10813079022654VascuChek Clinical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
07070554103444Medistim MiraQ Vascular SystemMedistim ASADPW2024-04-12
00817122020560VTI 8MHz TQI 2.0 Doppler TransceiverVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00817122020577Footswitch, MutingVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00817122020584Pole MountVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00627987360134Reprocess FloPatch1929803 Ontario CorpDPW2023-05-08
10627987360131Reprocess FloPatch1929803 Ontario CorpDPW2023-05-08
00627987360141Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
10627987360148Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
00627987360110Hydrogel Adhesive Strap1929803 Ontario CorpDPW2022-06-17
10627987360117Hydrogel Adhesive Strap1929803 Ontario CorpDPW2022-06-17
00627987360127Acrylate Adhesive Strap1929803 Ontario CorpDPW2022-06-17
10080196734290MedlineMEDLINE INDUSTRIES, INC.DPW2022-03-04