INSPIRA ART100

Basic Information

• Brand Name: INSPIRA ART100
• Primary DI: 07290117830147
• Version / Model: INSPIRA ART100 Flow Sensor 1/4"x1/16"
• Catalog Number: INS-011501
• 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: a0184d33-6322-4ef7-975f-f08daf821c94

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
62825	Extracorporeal fluid flow probe	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290117830144	GS1		1	In Commercial Distribution
Primary	07290117830147	GS1

Premarket Submissions

Submission Number	Supplement Number
K232788	000