FDA.reportPublic FDA data

Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir

Primary DI
00699753450073
Brand
Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir
Company
Terumo Cardiovascular Systems Corporation
Model
CX*SX25R
Published
2015-10-01
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
DTNReservoir, Blood, Cardiopulmonary Bypass
DTPDefoamer, Cardiopulmonary Bypass
DTRHeat-Exchanger, Cardiopulmonary Bypass
DTZOxygenator, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2
DTPDefoamer, Cardiopulmonary BypassCardiovascular2
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2
DTZOxygenator, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753450078PackageGS14In Commercial Distribution
00699753450073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975345007850699753450078
00699753450073006997534500736997534500730699753450073

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal membrane oxygenatorA device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. 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
00699753530638Cardiovascular Procedure Kit75972-022024-02-22
00699753532625Cardiovascular Procedure Kit783422024-08-09
00699753532311Cardiovascular Procedure Kit74737-022024-07-22
00699753532083Cardiovascular Procedure Kit77746-012024-07-09
00699753531734Cardiovascular Procedure Kit76373-022024-06-12
00699753531673Cardiovascular Procedure Kit74101-012024-06-07
00699753530492Cardiovascular Procedure Kit74005-032024-02-15
00699753478145Cardiovascular Procedure Kit737182014-10-08
00699753537705Cardiovascular Procedure Kit73344-052026-07-22
00699753537712Cardiovascular Procedure Kit76212-012026-07-22
00699753537729Cardiovascular Procedure Kit787422026-07-22
00699753537736Cardiovascular Procedure Kit788032026-07-22
00699753537651Cardiovascular Procedure KitCX-CZ219X2026-07-20
00699753537668Cardiovascular Procedure KitCX-CZ220X2026-07-20
00699753537675Cardiovascular Procedure KitCX-CZ221X2026-07-20
00699753537682Cardiovascular Procedure KitCX-CZ222X2026-07-20
00699753537699Cardiovascular Procedure Kit788022026-07-20
00699753537569Cardiovascular Procedure Kit787872026-07-08
00699753537576Cardiovascular Procedure Kit786052026-07-08
00699753537583Cardiovascular Procedure Kit787902026-07-08

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