FDA.reportPublic FDA data

Minimax®

Primary DI
00613994269782
Brand
Minimax®
Company
MEDTRONIC, INC.
Model
1316
Device description
RSVR 1316 MINIMAX INF STD ALN HRDSHL 4PK
Published
2015-06-09
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
DTPDefoamer, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTPDefoamer, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911789000MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILTMedtronic Vascular1991-08-20DTP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994269786PackageGS14Not in Commercial Distribution
00613994269782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399426978620613994269786
00613994269782006139942697826139942697820613994269782

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

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
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