Arterial Cannula

Primary DI
08033178000482
Brand
Arterial Cannula
Company
SORIN GROUP ITALIA SRL
Model
A212-45B
Published
2016-03-21
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
DQRCANNULA, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQRCannula, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K870826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870826000ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.Shiley, Inc.1987-03-23DQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178000483PackageGS110In Commercial Distribution
08033178000482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317800048338033178000483
08033178000482080331780004828033178000482

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, returnA semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.

Regulatory Flags#

DUNS number
442126587
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033178102933DHF02 HEMOCONCENTRATOR2015-07-15
08033178102940DHF06 HEMOCONCENTRATOR2015-07-15
08033178109062CSC 14CSC14 + PURGE LINE2015-07-10
08033178112253INSPIRE6M2015-05-13
08033178112277INSPIRE6F M2015-05-13
08033178112284INSPIRE8F M2015-05-13
08033178112291INSPIREHVR2015-05-13
08033178112307INSPIREHVR DUAL2015-05-13
08033178112352INSPIRE6 PH.I.S.I.O.2015-05-13
08033178112369INSPIRE8 PH.I.S.I.O.2015-05-13
08033178112376INSPIRE6F PH.I.S.I.O.2015-05-13
08033178112383INSPIRE8F PH.I.S.I.O.2015-05-13
08033178112390INSPIRE6 DUAL PH.I.S.I.O.2015-05-13
08033178112406INSPIRE8 DUAL PH.I.S.I.O.2015-05-13
08033178112413INSPIRE6F DUAL PH.I.S.I.O.2015-05-13
08033178112420INSPIRE8F DUAL PH.I.S.I.O.2015-05-13
08033178113014INSPIRESVR 12002017-03-29
08033178113182INSPIRE7 M2019-08-28
08033178113212INSPIRE72019-08-28
08033178113236INSPIRE7 DUAL2019-08-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840479401058enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401072enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479400174enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401041enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401065enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
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