FDA.reportPublic FDA data

Connector

Primary DI
00803622103148
Brand
Connector
Company
LIVANOVA USA, INC.
Model
AX-xxxxx
Published
2015-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTLADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K833322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833322000TUBING CONNECTORS EC-2XXX SERIESGish Biomedical, Inc.1983-12-16DTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622103145PackageGS120In Commercial Distribution
00803622103148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362210314510803622103145
00803622103148008036221031488036221031480803622103148

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system tubing connectorA sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.

Regulatory Flags#

DUNS number
080914995
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622164736Perfusion PackPerfusion Pack2026-09-29
00803622164743Perfusion PackPerfusion Pack2026-09-29
00803622164859Perfusion PackPerfusion Pack2026-09-29
00803622164651Perfusion PackPerfusion Pack2026-09-28
00803622164675Perfusion PackPerfusion Pack2026-09-28
00803622164682Perfusion PackPerfusion Pack2026-09-28
00803622164705Perfusion PackPerfusion Pack2026-09-28
00803622164712Perfusion PackPerfusion Pack2026-09-28
00803622164729Perfusion PackPerfusion Pack2026-09-28
00803622164767Perfusion PackPerfusion Pack2026-09-28
00803622164378Perfusion PackPerfusion Pack2026-09-22
00803622164477Perfusion PackPerfusion Pack2026-09-22
00803622164514Perfusion PackPerfusion Pack2026-09-22
00803622164569Perfusion PackPerfusion Pack2026-09-22
00803622164576Perfusion PackPerfusion Pack2026-09-22
00803622164583Perfusion PackPerfusion Pack2026-09-22
00803622164590Perfusion PackPerfusion Pack2026-09-22
00803622164606Perfusion PackPerfusion Pack2026-09-22
00803622164613Perfusion PackPerfusion Pack2026-09-22
00803622164668Perfusion PackPerfusion Pack2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889942000388NAMICMEDLINE INDUSTRIES, INC.DTL2026-08-18
10889942000395NAMICMEDLINE INDUSTRIES, INC.DTL2026-08-18
10889942000487NAMICMEDLINE INDUSTRIES, INC.DTL2026-08-17
00884450795705Merit Medical®Merit Medical Systems, Inc.DTL2026-07-21
10193489059199NAMICMEDLINE INDUSTRIES, INC.DTL2022-08-04
10193489064520NAMICMEDLINE INDUSTRIES, INC.DTL2022-08-04
10193489059151NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489059175NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489064506NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489059144NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489059168NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489059182NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064483NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064490NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064513NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489058819NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058840NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058857NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058864NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058871NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058932NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058949NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058970NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
H965814001240NAMICANGIODYNAMICS, INC.DTL2020-11-03
07613327459210AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459180AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08
07613327459197AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08
07613327459203AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08