FDA.reportPublic FDA data

NA

Primary DI
04037691032528
Brand
NA
Company
Maquet Cardiopulmonary AG
Model
VBT Venous Bubble Trap
Catalog number
70102.9805
Published
2015-10-24
Public version status
Update
Distribution status
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
DTPDefoamer, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTPDefoamer, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082412000VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160Mapquet Cardiopulmonary AG2008-11-10DTP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04037691032528PackageGS18In Commercial Distribution
04037691209722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04037691032528040376910325284037691032528
04037691209722040376912097224037691209722

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion filterA microporous device intended to be inserted, e.g., into a blood transfusion line, to remove debris from blood being infused into a patient. When used for arterial blood the device may also be used to trap gaseous (air) bubbles. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume160Milliliter

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033178113359INSPIRESORIN GROUP ITALIA SRLDTP2021-04-13
08033178113366INSPIRESORIN GROUP ITALIA SRLDTP2021-04-13
00699753450868NX19 Oxygenator w/4-liter reservoir; right-side outlet portTerumo Cardiovascular Systems CorporationDTP2021-03-18
00699753450875NX19 Oxygenator w/4-liter reservoir; left-side outlet portTerumo Cardiovascular Systems CorporationDTP2021-03-18
04058863019222QUADROX-iMaquet Cardiopulmonary AGDTP2017-10-12
04037691075051VBT Venous Bubble TrapMaquet Cardiopulmonary AGDTP2017-03-13
04037691075068VBT Venous Bubble TrapMaquet Cardiopulmonary AGDTP2017-03-13
04037691576350MACEMaquet Cardiopulmonary AGDTP2017-03-13
04037691665726MACEMaquet Cardiopulmonary AGDTP2017-03-13
04037691665733MACEMaquet Cardiopulmonary AGDTP2017-03-13
04037691838663VHK Venous ReservoirMaquet Cardiopulmonary AGDTP2017-03-13
04037691854984VHK reservoir AdMaquet Cardiopulmonary AGDTP2017-03-13
04058863017792Quadrox-iMaquet Cardiopulmonary AGDTP2017-03-13
04058863007403QUADROX-iMaquet Cardiopulmonary AGDTP2017-02-16
04058863018843QUADROX-iMaquet Cardiopulmonary AGDTP2017-02-16
04058863005805QUADROX-iMaquet Cardiopulmonary AGDTP2017-02-15
04058863018867QUADROX-iMaquet Cardiopulmonary AGDTP2017-02-15
00643169767645Intersept™MEDTRONIC, INC.DTP2017-02-05
B066H11360STANDARD VAVD KITNOVOSCI CORP.DTP2016-09-26
B066H11363Standard VAVD KitNOVOSCI CORP.DTP2016-09-26
04037692010006QUADROX-iMaquet Cardiopulmonary AGDTP2015-12-15
04037692009987QUADROX-iMaquet Cardiopulmonary AGDTP2015-12-15
04037692009994QUADROX-iMaquet Cardiopulmonary AGDTP2015-12-15
04037692010013QUADROX-iMaquet Cardiopulmonary AGDTP2015-12-15
04037691209722NAMaquet Cardiopulmonary AGDTP2015-10-24
04037691572758NAMaquet Cardiopulmonary AGDTP2015-10-24
04037691773414QUADROX-iMaquet Cardiopulmonary AGDTP2015-10-24
04037691775388QUADROX-iMaquet Cardiopulmonary AGDTP2015-10-24
04037691780139QUADROX-iMaquet Cardiopulmonary AGDTP2015-10-24
04037691780542QUADROX-iMaquet Cardiopulmonary AGDTP2015-10-24