FDA.reportPublic FDA data

Standard VAVD Kit

Primary DI
B066H11363
Brand
Standard VAVD Kit
Company
NOVOSCI CORP.
Model
H-1136
Catalog number
H-1136
Device description
A collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions during cardiopulmonar
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
K990514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990514000MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VRC.R. Bard, Inc.1999-03-09DTP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B066H11363PackageHIBCC10In Commercial Distribution
B066H11360PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardioplegia solution administration kitA collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
938289980
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0662010110000STOPCOCK, TMP 3-WAY W/LUER LOCK201011-000201011-0002015-09-14
B0662010120000STOPCOCK, TMP 4-WAY W/LUER LOCK201012-000201012-0002015-09-14
B0663110330000TUBING ORGANIZER - STERILE311033-000311033-0002015-10-06
B066311033NS1TUBING ORGANIZER - NON-STERILE 311033NS311033NS2015-10-13
B0663110340000PEDIATRIC TUBING ORGANIZER - STERILE311034-000311034-0002015-10-12
B066311034NS1PEDIATRIC TUBING ORGANIZRER - NON-STERILE311034NS311034NS2015-10-13
B066321244NS1"CONNECTOR, 1/4"" X 1/2"" X 1/2"" CLEAR PAY "321244NS321244NS2015-10-13
B066201006NS1CANNULAE, SAPHENOUS VEIN201006NS201006NS2015-11-11
B066301011NS1"QUICKIE PRIME - 1/4"" x 1/16"""301011NS301011NS2017-12-06
B066331011NS1"CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE "331011NS331011NS2015-10-13
B066331012NS1"CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE"331012NS331012NS2015-10-13
B066331022NS1"CONNECTOR, 1/4"" X 1/4"" W/OUT PART LINE"331022NS331022NS2015-10-13
B066331023NS1"CONNECTOR, 1/4"" X 3/8"" W/OUT PART LINE"331023NS331023NS2015-10-13
B066331024NS1"CONNECTOR, 1/4"" X 1/2"" W/OUT LUER "331024NS331024NS2015-10-13
B066331033NS1"CONNECTOR, 3/8"" X 3/8"" W/OUT PART LINE"331033NS331033NS2015-10-13
B066331034NS1"CONNECTOR, 3/8"" X 1/2"" W/OUT PART LINE"331034NS331034NS2015-10-13
B066331044NS1"CONNECTOR, 1/2"" X 1/2"" W/OUT PART LINE"331044NS331044NS2015-10-13
B066332011NS1"CONNECTOR, 3/16"" X 3/16"" W/OUT PART LINE W/LUER"332011NS332011NS2015-10-13
B066332012NS1"CONNECTOR, 3/16"" X 1/4"" W/OUT PART LINE W/LUER"332012NS332012NS2015-10-13
B066332022NS1"CONNECTOR, 1/4"" X 1/4"" W/LUER"332022NS332022NS2015-10-13

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
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
04037691032528NAMaquet 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