FDA.reportPublic FDA data

INSPIRA CART

Primary DI
07290117830079
Brand
INSPIRA CART
Company
INSPIRA TECHNOLOGIES OXY B.H.N LTD
Model
INSPIRA CART
Catalog number
INS-010401
Published
2024-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
17290117830076PackageGS11In Commercial Distribution
07290117830079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011783007617290117830076
07290117830079072901178300797290117830079

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.

Regulatory Flags#

DUNS number
531834876
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117830086INSPIRA ART100 Packed INSPIRA ART100 HoldersINS-011101P2024-11-10
07290117830055INSPIRA ART100 INSPIRA ART100 Pump DriveINS-0102012024-11-10
07290117830062INSPIRA ART100 INSPIRA ART100 Emergency Manual Pump DriveINS-0103012024-11-10
07290117830093INSPIRA ART100 "INSPIRA ART100 Flow Sensor 3/8""x3/32"""INS-0106012024-11-10
07290117830147INSPIRA ART100 "INSPIRA ART100 Flow Sensor 1/4""x1/16"""INS-0115012024-11-10
07290117830048INSPIRA ART100 INSPIRA ART100 ControllerINS-0101012024-11-10
17290117830052INSPIRA ART100 INSPIRA ART100 Pump DriveINS-0102012024-11-10
17290117830069INSPIRA ART100 INSPIRA ART100 Emergency Manual Pump DriveINS-0103012024-11-10
17290117830076INSPIRA CARTINSPIRA CARTINS-0104012024-11-10
17290117830090INSPIRA ART100 INSPIRA ART100 Flow Sensor 3/8"x3/32"INS-0106012024-11-10
07290117830109INSPIRA ART100 INSPIRA ART100 Cables Set & Temperature SensorINS-0105012024-11-10
07290117830116INSPIRA ART100 Packed INSPIRA ART100 SystemINS-010801P2024-11-10
17290117830144INSPIRA ART100 INSPIRA ART100 Flow Sensor 1/4"x1/16"INS-0115012024-11-10

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
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
08033178112987InspireSORIN GROUP ITALIA SRLKRI2023-10-24