FDA.reportPublic FDA data

NA

Primary DI
04037691021935
Brand
NA
Company
Maquet Cardiopulmonary AG
Model
Ven.Cath.,reinf.,F.Lumen tip,90°bent
Catalog number
70102.3325
Device description
Venous Catheter, wire reinforced with Full Lumen tip, 90° bent
Published
2015-10-24
Public version status
Update
Distribution status
Not 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
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872182000POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAEPolystan C/O Vitalcor, Inc.1987-10-30DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04037691021935PackageGS110Not in Commercial Distribution
04037691245973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04037691021935040376910219354037691021935
04037691245973040376912459734037691245973

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula, venousA sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted, typically into the right atrium and superior/inferior vena cava, to serve as a channel for the transport of blood to a cardiopulmonary bypass system (heart-lung machine) tubing circuit where the blood is pumped and oxygenated. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, and having multiple perforations at the distal end and possibly a non-reinforced clamping site at the proximal end. It is typically inserted using a compatible trocar. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Device Size Text, specify0
Length25Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
316153865
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
true
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
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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