INSPIRA ART100

Basic Information

• Brand Name: INSPIRA ART100
• Primary DI: 07290117830109
• Version / Model: INSPIRA ART100 Cables Set & Temperature Sensor
• Catalog Number: INS-010501
• Company Name: INSPIRA TECHNOLOGIES OXY B.H.N LTD
• Labeler DUNS: 531834876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-10
• Public Version: 1
• Public Version Date: 2024-11-18
• Public Version Status: New
• Public Device Record Key: a2248cd6-619a-4e5a-ae93-30956a01959f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	870.4380	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36374	Cardiopulmonary bypass system temperature control unit	An electronic device that is a module of a cardiopulmonary bypass system and that is used to measure and display the temperatures of the different temperature probes that are connected into the total system in order to monitor the fluid and blood temperatures at various points. It may also control the temperature levels, e.g., the temperature level of the fluid entering and leaving the heat exchanger.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290117830109	GS1
Package	17290117830106	GS1		1	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K232788	000