FDA.reportPublic FDA data

CAPIOX

Primary DI
04987350705693
Brand
CAPIOX
Company
TERUMO CORPORATION
Model
CX*BT05
Device description
CAPIOX Bubble Trap
Published
2016-09-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRLDETECTOR, BUBBLE, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRLDetector, Bubble, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350705698PackageGS110In Commercial Distribution
04987350705693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735070569854987350705698
04987350705693049873507056934987350705693

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system defoamerA sterile device that is used remove gas bubbles from the blood during cardiopulmonary bypass surgery and is used in conjunction with an oxygenator [the device used to add the necessary oxygen (O2) to the blood before being returned back to the patient]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature1 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Fragile. Keep away from sunlight. This way up
Special Storage Condition, Specify00Keep away from rain.

Contacts#

Phone, Email table
PhoneEmail
+1(800)521-2818xx@xx.xx

Regulatory Flags#

DUNS number
690543319
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350717948GLIDESHEATH SLENDERRM*ES6J10HATRM*ES6J10HAT2016-09-09
04987350717962GLIDESHEATH SLENDERRM*ES6J16HATRM*ES6J16HAT2016-09-09
04987350717986GLIDESHEATH SLENDERRM*ES6F10HAURM*ES6F10HAU2016-09-09
04987350718006GLIDESHEATH SLENDERRM*ES6F16HAURM*ES6F16HAU2016-09-09
04987350718020GLIDESHEATH SLENDERRM*RS6J10PARM*RS6J10PA2016-09-09
04987350718044GLIDESHEATH SLENDERRM*RS6J16PARM*RS6J16PA2016-09-09
04987350718068GLIDESHEATH SLENDERRM*RS6F10PARM*RS6F10PA2016-09-09
04987350718082GLIDESHEATH SLENDERRM*RS6F16PARM*RS6F16PA2016-09-09
04987350722607GLIDESHEATH SLENDERRM*ES5J10HATRM*ES5J10HAT2016-09-09
04987350722621GLIDESHEATH SLENDERRM*ES5J16HATRM*ES5J16HAT2016-09-09
04987350722645GLIDESHEATH SLENDERRM*ES5F10HAURM*ES5F10HAU2016-09-09
04987350722669GLIDESHEATH SLENDERRM*ES5F16HAURM*ES5F16HAU2016-09-09
04987350722720GLIDESHEATH SLENDERRM*RS5J10PARM*RS5J10PA2016-09-09
04987350722744GLIDESHEATH SLENDERRM*RS5J16PARM*RS5J16PA2016-09-09
04987350722768GLIDESHEATH SLENDERRM*RS5F10PARM*RS5F10PA2016-09-09
04987350722782GLIDESHEATH SLENDERRM*RS5F16PARM*RS5F16PA2016-09-09
04987350723048GLIDESHEATH SLENDERRM*ES7J10HATRM*ES7J10HAT2016-09-09
04987350723062GLIDESHEATH SLENDERRM*ES7J16HATRM*ES7J16HAT2016-09-09
04987350723086GLIDESHEATH SLENDERRM*ES7F10HAURM*ES7F10HAU2016-09-09
04987350723109GLIDESHEATH SLENDERRM*ES7F16HAURM*ES7F16HAU2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886799000212Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2016-09-23
00886799000229Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2016-09-23
00886799000236Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2016-09-23
00886799000342Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2016-09-23
00886799001721Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2016-09-23
04987350705730CAPIOXTERUMO CORPORATIONKRL2016-09-09
54987350705698CAPIOXTERUMO CORPORATIONKRL2016-09-09
54987350705735CAPIOXTERUMO CORPORATIONKRL2016-09-09
00886799000199Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2015-09-24