FDA.reportPublic FDA data

INSPIRA ART100

Primary DI
17290117830144
Brand
INSPIRA ART100
Company
INSPIRA TECHNOLOGIES OXY B.H.N LTD
Model
INSPIRA ART100 Flow Sensor 1/4"x1/16"
Catalog number
INS-011501
Published
2024-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
17290117830144PackageGS11In Commercial Distribution
07290117830147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011783014417290117830144
07290117830147072901178301477290117830147

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal fluid flow probeAn electronic device intended to be used to measure rate of fluid flow in an extracorporeal perfusion system tube using ultrasound transit time technology. It typically clamps over the exterior of a flexible tube and is used in conjunction with a flowmeter/flowmeter board incorporated into the perfusion system. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
531834876
Device count
1
DM exempt
false
Premarket exempt
false
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
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

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
07290117830062INSPIRA 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
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