FDA.reportPublic FDA data

INSPIRA CART

Primary DI
17290117830076
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
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
531834876
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07290117830079INSPIRA CARTINSPIRA CARTINS-0104012024-11-10
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
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
07290117830079INSPIRA 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