FDA.reportPublic FDA data

NA

Primary DI
04037691183176
Brand
NA
Company
Maquet Cardiopulmonary AG
Model
Art.Can.,reinf.,straight tip w/o ring
Catalog number
70100.2374
Device description
Arterial Cannula, wire reinforced, straight tip without ring
Published
2015-11-12
Public version status
Update
Distribution status
Not 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
DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072172000JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAEMaquet Cardiopulmonary, AG2007-08-31DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04037691090269PackageGS110Not in Commercial Distribution
04037691183176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04037691090269040376910902694037691090269
04037691183176040376911831764037691183176

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Device Size Text, specify0
Length23Centimeter

Contacts#

Phone, Email table
PhoneEmail
+49072229320info.cp@maquet.com

Regulatory Flags#

DUNS number
316153865
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04037691650326ROTAFLOWCentrifugal Pump, SOFTLINE70104.75532015-10-30
04037691645148NACARDIOHELP Emergency Drive holder, Rail70104.93042016-02-29
04037691645155NACARDIOHELP Emergency Drive Holder, Mast70104.80062016-02-29
04037691720791NACARDIOHELP Holder for mast HKH 9102-M70104.95842016-02-29
04037691456584NAWall holder HKH 882070104.53662016-02-29
04037691717968NACardiohelp Mobile Holder HKH 886070105.08972016-02-29
04037691718330NAGas bottle holder f. helicopter HKH 888070105.09012016-02-29
04058863084336CardiohelpMobile Holder HKH 886070107.3079 2018-03-01
04037691075051VBT Venous Bubble TrapBEQ-VBT 160, BIOLINE, Sterile70103.08842017-03-13
04037691209722NAVBT Venous Bubble Trap70102.98052015-10-24
04037691349251BMU 40"BMU 40 Cell 1/2"""70104.08042016-01-18
04037691349268BMU 40"BMU 40 Cell 3/8"""70104.08442016-01-18
04037691349275BMU 40"BMU 40 Cell 1/4"""70104.08452016-01-18
04037691349282BMU 40"BMU 40 Sensor 3/8"""70104.08492016-01-18
04037691349299BMU 40"BMU 40 Sensor 1/4"""70104.08502016-01-18
04037691349305BMU 40"BMU 40 Sensor 3/16"""70104.08512016-01-18
04037691670164QUADROX-iPediatric, diffusion, BIOLINE70105.03302015-10-24
04037691770970QUADROX-iPediatric, filter70105.52152015-10-24
04058863017341QUADROX-iHMO 71000-USA #SQUADROX-i Adult + Coating, Filter70106.78232017-02-16
04058863017372QUADROX-iBEQ-HMO 71000-USA #SQUADROX-i Adult+BIOLINE +Filte70106.78292017-02-16

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Primary DI, Brand, Company table
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08033178017251Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
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