INSPIRE

GUDID 38033178112421

SORIN GROUP ITALIA SRL

Extracorporeal membrane oxygenator

• Primary Device ID: 38033178112421
• NIH Device Record Key: b1a6a34e-c191-40db-a8a2-c8749f5c0384
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSPIRE
• Version Model Number: 8F DUAL PH.I.S.I.O.
• Company DUNS: 442126587
• Company Name: SORIN GROUP ITALIA SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08033178112420 [Primary]
GS1	38033178112421 [Package]; Contains: 08033178112420; Package: BOX [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122844

FDA Product Code

• DTZ: OXYGENATOR, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2015-05-13

On-Brand Devices [INSPIRE]

• 38033178113237: 7 DUAL
• 38033178113213: 7
• 38033178113183: 7 M
• 38033178113015: SVR 1200
• 38033178112421: 8F DUAL PH.I.S.I.O.
• 38033178112414: 6F DUAL PH.I.S.I.O.
• 38033178112407: 8 DUAL PH.I.S.I.O.
• 38033178112391: 6 DUAL PH.I.S.I.O.
• 38033178112384: 8F PH.I.S.I.O.
• 38033178112377: 6F PH.I.S.I.O.
• 38033178112360: 8 PH.I.S.I.O.
• 38033178112353: 6 PH.I.S.I.O.
• 38033178112308: HVR DUAL
• 38033178112292: HVR
• 38033178112285: 8F M
• 38033178112278: 6F M
• 38033178112261: 8M
• 38033178112254: 6M
• 38033178113367: 7F DUAL
• 38033178113350: 7F
• 38033178113343: 7F M
• 08033178112994: Bracket
• 08033178112987: Bracket 1200
• 08033178112970: Bracket
• 08033178111966: Bracket
• 08033178111959: Bracket