INSPIRA ART100

Basic Information

• Brand Name: INSPIRA ART100
• Primary DI: 07290117830062
• Version / Model: INSPIRA ART100 Emergency Manual Pump Drive
• Catalog Number: INS-010301
• 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: 137bb6b5-dc1f-4f8a-bb41-0e2722bf1cb2

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
36858	Centrifugal circulatory assist pump, manual	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290117830069	GS1		1	In Commercial Distribution
Primary	07290117830062	GS1

Premarket Submissions

Submission Number	Supplement Number
K232788	000