FDA.reportPublic FDA data

INSPIRA ART100

Primary DI
07290117830062
Brand
INSPIRA ART100
Company
INSPIRA TECHNOLOGIES OXY B.H.N LTD
Model
INSPIRA ART100 Emergency Manual Pump Drive
Catalog number
INS-010301
Published
2024-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWAControl, Pump Speed, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWAControl, Pump Speed, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232788000INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.2024-05-24DWA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290117830069PackageGS11In Commercial Distribution
07290117830062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011783006917290117830069
07290117830062072901178300627290117830062

GMDN Terms#

Term, Definition table
TermDefinition
Centrifugal circulatory assist pump, manualA centrifugal pump that is manually hand cranked (rotated) by the perfusionist or operator present in order to substitute for the electrically-operated pump during a power outage. It is a specially constructed pump used to provide circulatory assistance (support of the blood circulation when the heart fails) to the patient due to his/her dependence upon artificial assistance in order to maintain the body's heart function.

Regulatory Flags#

DUNS number
531834876
Device count
1
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
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
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
07640135140153CentriMag™Thoratec CorporationDWA2026-02-19
00850000067141Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2025-08-26
07290117830055INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830093INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830147INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830048INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830052INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830069INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830086INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830090INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830109INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830116INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830144INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
00850000067059Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067066Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067073Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067080Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067097Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067103Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067110Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067127Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
04897102200065Anivia SG1000 Pump ConsoleAsia Pacific Medical Technology Development Company LimitedDWA2024-09-11
05415067036414CentriMag™Thoratec CorporationDWA2023-05-17
00763000301347NAMEDTRONIC, INC.DWA2023-03-18
00814112020586LifeSPARCCARDIACASSIST, INC.DWA2023-02-24
00814112020906LifeSPARCCARDIACASSIST, INC.DWA2022-05-10
04033817902782CP5LivaNova Deutschland GmbHDWA2021-05-14
10860001797968OXY-1 SystemBreethe, Inc.DWA2020-12-02
00860001797961OXY-1 SystemBreethe, Inc.DWA2020-12-02
00860001797909Abiomed Breethe OXY-1 SystemBreethe, Inc.DWA2020-11-30