Arterial Cannula

GUDID 38033178001473

SORIN GROUP ITALIA SRL

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial

• Primary Device ID: 38033178001473
• NIH Device Record Key: c51a2149-a83f-4171-8245-0a7b11f140ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arterial Cannula
• Version Model Number: A222-52B
• 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	08033178001472 [Primary]
GS1	38033178001473 [Package]; Contains: 08033178001472; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870826

FDA Product Code

• DQR: CANNULA, CATHETER

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: 2022-08-05
• Device Publish Date: 2016-03-21

On-Brand Devices [Arterial Cannula]

• 38033178011991: A281-80B
• 38033178011861: A282-80B
• 38033178011496: A291-80B
• 38033178011472: A281-80A
• 38033178011458: A282-80A
• 38033178011427: A292-80C
• 38033178011410: A291-80C
• 38033178008540: A212-73A
• 38033178008526: A212-73B
• 38033178008489: A212-73C
• 38033178005556: A292-80B
• 38033178005549: A292-70C
• 38033178005440: A281-70C
• 38033178005204: A291-70C
• 38033178005181: A291-70B
• 38033178005075: A282-80C
• 38033178004986: A282-70C
• 38033178004979: A282-70B
• 38033178004962: A282-70A
• 38033178004856: A292-70B
• 38033178004788: A281-70B
• 38033178003897: A281-80C
• 38033178003316: A262-80C
• 38033178003309: A262-65C
• 38033178003170: A262-80B
• 38033178003163: A262-65B
• 38033178003026: A262-65A
• 38033178002470: A232-80C
• 38033178002463: A232-65C
• 38033178002456: A232-52C
• 38033178002449: A232-45C
• 38033178002432: A232-38C
• 38033178002425: A232-30C
• 38033178002333: A232-80B
• 38033178002326: A232-65B
• 38033178002319: A232-52B
• 38033178002302: A232-45B
• 38033178002296: A232-38B
• 38033178002289: A232-30B
• 38033178002180: A232-65A
• 38033178001633: A222-80C
• 38033178001626: A222-65C
• 38033178001619: A222-52C
• 38033178001602: A222-45C
• 38033178001596: A222-38C
• 38033178001589: A222-30C
• 38033178001534: A221-45C
• 38033178001527: A221-38C
• 38033178001510: A221-30C
• 38033178001497: A222-80B