FDA.reportPublic FDA data

VHK Venous Reservoir

Primary DI
04037691838663
Brand
VHK Venous Reservoir
Company
Maquet Cardiopulmonary AG
Model
BO-VHK 71000, Adult, SOFTLINE, Sterile
Catalog number
70106.3858
Device description
Venous Hardshell Cardiotomy Reservoir, Adult, Vacuum-tight, with SOFTLINE Coating, without screw connector, Sterile. The Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood. The vacuum-tight version of the VHK reservoir (VHK 71000) can also be employed postoperatively as drainage and auto-transfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.
Published
2017-03-13
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
DTNRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
DTPDefoamer, cardiopulmonary bypass
JODFILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2
DTPDefoamer, Cardiopulmonary BypassCardiovascular2
JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132166000VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTMaquet Cardiopulmonary, AG2013-10-30DTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04037691838663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04037691838663040376918386634037691838663

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotomy reservoirA device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Pore Size68Micrometer
Total Volume4200Milliliter

Sterilization Methods#

Method table
Method

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
04037691831039AVALON ELITEVAK70106.35402016-01-13
04037691831046AVALON ELITEVAK70106.35392016-01-13
04037691730660NAPIK 10070105.30682015-11-04
04037691730677NAPIK 15070105.30692015-11-04
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

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