INSPIRA ART100

Basic Information

• Brand Name: INSPIRA ART100
• Primary DI: 07290117830086
• Version / Model: Packed INSPIRA ART100 Holders
• Catalog Number: INS-011101P
• 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: 2
• Public Version Date: 2024-12-11
• Public Version Status: Update
• Public Device Record Key: 5716547a-e71f-4758-8ba0-4aa911ad0f90

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: No
• Has Lot/Batch Number: Yes
• 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
35954	Medical device rail	A device in the form of a narrow bar designed to be fixed on the wall for mounting and organizing medical devices [e.g., in hospital wards, treatment rooms, intensive care units (ICU)]; the equipment to be supported is not included. It may be used in conjunction with clamps and/or poles. It is available in various lengths.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290117830086	GS1

Premarket Submissions

Submission Number	Supplement Number
K232788	000