FDA.reportPublic FDA data

CAPIOX

Primary DI
54987350705735
Brand
CAPIOX
Company
TERUMO CORPORATION
Model
CX*BT15
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
OTC
false
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
54987350705735PackageGS110In Commercial Distribution
04987350705730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735070573554987350705735
04987350705730049873507057304987350705730

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.

Sterilization Methods#

Method table
Method

Contacts#

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

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
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
04987350705693CAPIOXTERUMO CORPORATIONKRL2016-09-09
04987350705730CAPIOXTERUMO CORPORATIONKRL2016-09-09
54987350705698CAPIOXTERUMO CORPORATIONKRL2016-09-09
00886799000199Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationKRL2015-09-24