INSPIRA ART100 INS-010101

GUDID 07290117830048

INSPIRA TECHNOLOGIES OXY B.H.N LTD

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 07290117830048
• NIH Device Record Key: 1ffe8d67-e84e-492d-bf30-f67e282830c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSPIRA ART100
• Version Model Number: INSPIRA ART100 Controller
• Catalog Number: INS-010101
• Company DUNS: 531834876
• Company Name: INSPIRA TECHNOLOGIES OXY B.H.N LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290117830048 [Primary]
GS1	17290117830045 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232788

FDA Product Code

• DWA: Control, Pump Speed, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-18
• Device Publish Date: 2024-11-10

On-Brand Devices [INSPIRA ART100 ]

• 17290117830144: INSPIRA ART100 Flow Sensor 1/4"x1/16"
• 07290117830116: Packed INSPIRA ART100 System
• 07290117830109: INSPIRA ART100 Cables Set & Temperature Sensor
• 17290117830090: INSPIRA ART100 Flow Sensor 3/8"x3/32"
• 07290117830086: Packed INSPIRA ART100 Holders
• 17290117830069: INSPIRA ART100 Emergency Manual Pump Drive
• 17290117830052: INSPIRA ART100 Pump Drive
• 07290117830048: INSPIRA ART100 Controller