FDA.reportPublic FDA data

Tubing Organizer

Primary DI
00803622128370
Brand
Tubing Organizer
Company
LIVANOVA USA, INC.
Model
AX-xxxxx
Published
2015-09-22
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
KRIACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622128377PackageGS110In Commercial Distribution
00803622128370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362212837710803622128377
00803622128370008036221283708036221283700803622128370

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, belt or strap intended to pass through the personal device’s slots, or clothing. This is a single-use device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622163456Perfusion PackPerfusion Pack2026-05-18
00803622163463Perfusion PackPerfusion Pack2026-05-18
00803622163470Perfusion PackPerfusion Pack2026-05-18
00803622163500Perfusion PackPerfusion Pack2026-05-18
00803622163531Perfusion PackPerfusion Pack2026-05-18
00803622163555Perfusion PackPerfusion Pack2026-05-18
00803622163562Perfusion PackPerfusion Pack2026-05-18
00803622163579Perfusion PackPerfusion Pack2026-05-18
00803622163739Perfusion PackPerfusion Pack2026-05-18
00803622161506Perfusion PackPerfusion Pack2026-05-08
00803622162145Perfusion PackPerfusion Pack2026-05-08
00803622163418Perfusion PackPerfusion Pack2026-05-08
00803622163432Perfusion PackPerfusion Pack2026-05-08
00803622163449Perfusion PackPerfusion Pack2026-05-08
00803622163517Perfusion PackPerfusion Pack2026-05-08
00803622163494Perfusion PackPerfusion Pack2026-05-05
00803622163340Perfusion PackPerfusion Pack2026-05-04
00803622163357Perfusion PackPerfusion Pack2026-05-04
00803622163364Perfusion PackPerfusion Pack2026-05-04
00803622163388Perfusion PackPerfusion Pack2026-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18051160302137Quantum Perfusion Capnometer Line SetSPECTRUM MEDICAL SRLKRI2026-05-21
28051160301564Quantum PureFlow KIT CPC - Barbed Connector AdaptorSPECTRUM MEDICAL SRLKRI2026-05-21
28051160301571Quantum PureFlow KIT CPC - Hansen Connector AdaptorSPECTRUM MEDICAL SRLKRI2026-05-21
08052595517144HOLDEREUROSETS SRLKRI2026-05-05
08052595517458HOLDEREUROSETS SRLKRI2026-05-05
08052595517465HOLDEREUROSETS SRLKRI2026-05-05
05060434424457QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-20
05060434424532QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-09
05415067034441CentriMag™Thoratec CorporationKRI2026-02-02
00850054036629Cardio Quip VivaCart Short Infusion Pole with Removable HooksCARDIOQUIP, LLCKRI2025-10-28
08034013785489HOLDEREUROSETS SRLKRI2025-02-19
07290117830079INSPIRA CARTINSPIRA TECHNOLOGIES OXY B.H.N LTDKRI2024-11-10
17290117830076INSPIRA CARTINSPIRA TECHNOLOGIES OXY B.H.N LTDKRI2024-11-10
10850007732353VitalFlow CaddyMICHIGAN CRITICAL CARE CONSULTANTS, INC.KRI2024-09-19
05060434423962QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
05060434423979QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
05060434423986Quantum SPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423966QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423973QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423980Quantum SPECTRUM MEDICAL LIMITEDKRI2023-12-22
08033178101547Sinergy and Mini Bag CPBSORIN GROUP ITALIA SRLKRI2023-10-24
08033178101622Vanguard, CSC 14 and HSCSORIN GROUP ITALIA SRLKRI2023-10-24
08033178102292DAC CardiotomySORIN GROUP ITALIA SRLKRI2023-10-24
08033178102384ExchangerSORIN GROUP ITALIA SRLKRI2023-10-24
08033178103428HemoconcentratorSORIN GROUP ITALIA SRLKRI2023-10-24
08033178109857D100/D101SORIN GROUP ITALIA SRLKRI2023-10-24
08033178109864D130/D131 KIDS Arterial FilterSORIN GROUP ITALIA SRLKRI2023-10-24
08033178111959InspireSORIN GROUP ITALIA SRLKRI2023-10-24
08033178111966InspireSORIN GROUP ITALIA SRLKRI2023-10-24
08033178112970InspireSORIN GROUP ITALIA SRLKRI2023-10-24