FDA.reportPublic FDA data

CAPIOX

Primary DI
04987350733658
Brand
CAPIOX
Company
TERUMO CORPORATION
Model
XX*CXH18
Catalog number
XX*CXH18
Device description
Device Holder
Published
2022-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRIACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350733653PackageGS14In Commercial Distribution
04987350733658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735073365354987350733653
04987350733658049873507336584987350733658

GMDN Terms#

Term, Definition table
TermDefinition
Medical device service rail clampA clamp designed to fit onto a medical device mounting rail or medical device service rail system to provide a secure method of fixing/mounting (holding) other medical or non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in a hospital ward, a treatment room or an intensive care unit (ICU). It will have a gripping profile that is compatible to the medical rail it is intended to fit and a locking mechanism providing extra safety against inadvertent loosening. To this clamp, other adaptors may be fitted/slotted to provide holders for the devices to be carried, or it may have a dedicated function for which it is solely designed.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This way up,Fragile. Keep dry. Keep away from sunlight.

Contacts#

Phone, Email table
PhoneEmail
+1(800)521-2818cvscustomerservice@terumomedical.com

Regulatory Flags#

DUNS number
690543319
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350722164Misago®SXR07040LSX*FXA0740LN2015-05-30
04987350722188Misago®SXR07060LSX*FXA0760LN2015-05-30
04987350722348Misago®SXR08100LSX*FXA08X0LN2015-05-30
04987350722089Misago®SXR06060LSX*FXA0660LN2015-05-30
04987350722102Misago®SXR06080LSX*FXA0680LN2015-05-30
04987350722126Misago®SXR06120LSX*FXA06X2LN2015-05-30
04987350722140Misago®SXR06150LSX*FXA06X5LN2015-05-30
04987350722201Misago®SXR07080LSX*FXA0780LN2015-05-30
04987350722225Misago®SXR07100LSX*FXA07X0LN2015-05-30
04987350722287Misago®SXR08040LSX*FXA0840LN2015-05-30
04987350722300Misago®SXR08060LSX*FXA0860LN2015-05-30
04987350722324Misago®SXR08080LSX*FXA0880LN2015-05-30
04987350722362Misago®SXR06100LSX*FXA06X0LN2015-05-30
04987350722065Misago®SXR06040LSX*FXA0640LN2015-05-30
04987350722249Misago®SXR07120LSX*FXA07X2LN2015-05-30
04987350722263Misago®SXR07150LSX*FXA07X5LN2015-05-30
04987350739124CAPIOXCX*FX05WACX*FX05WA2021-07-06
04987350739100CAPIOXCX*FX05EACX*FX05EA2021-07-01
04987350781710CAPIOX®FXCX*FX05E2015-09-15
04987350781734CAPIOX®FXCX*FX05W2015-09-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08033178103428HemoconcentratorSORIN GROUP ITALIA SRLKRI2023-10-24
08033178109857D100/D101SORIN GROUP ITALIA SRLKRI2023-10-24
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