PureFlex Arterial Cannulae

GUDID 38033178016927

SORIN GROUP ITALIA SRL

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial

• Primary Device ID: 38033178016927
• NIH Device Record Key: 9967aa84-8fee-49b0-9dd7-0b23140f270a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureFlex Arterial Cannulae
• Version Model Number: RA20-1BP Bent collar tip
• 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	08033178016926 [Primary]
GS1	38033178016927 [Package]; Contains: 08033178016926; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180979

FDA Product Code

• DWF: Catheter, cannula and tubing, vascular, 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: 2
• Public Version Date: 2022-08-05
• Device Publish Date: 2019-02-05

On-Brand Devices [PureFlex Arterial Cannulae]

• 38033178017139: RA18-1BC Bent collar tip
• 38033178017122: RA18-1BB Bent collar tip
• 38033178017115: RA24-2BC Bent flange tip
• 38033178017108: RA24-1BP Bent collar tip
• 38033178017092: RA24-1BC Bent collar tip
• 38033178017085: RA24-1BB Bent collar tip
• 38033178017078: RA22-2BP Bent flange tip
• 38033178017061: RA22-2BC Bent flange tip
• 38033178017054: RA22-2BB Bent flange tip
• 38033178017047: RA22-1SP Straight collar tip
• 38033178017030: RA22-1SC Straight collar tip
• 38033178017023: RA22-1SB Straight collar tip
• 38033178017016: RA22-1BP Bent collar tip
• 38033178017009: RA22-1BC Bent collar tip
• 38033178016996: RA22-1BB Bent collar tip
• 38033178016989: RA20-2BP Bent flange tip
• 38033178016972: RA20-2BC Bent flange tip
• 38033178016965: RA20-2BB Bent flange tip
• 38033178016958: RA20-1SP Straight collar tip
• 38033178016941: RA20-1SC Straight collar tip
• 38033178016934: RA20-1SB Straight collar tip
• 38033178016927: RA20-1BP Bent collar tip
• 38033178016910: RA20-1BC Bent collar tip
• 38033178016903: RA20-1BB Bent collar tip
• 38033178016897: RA18-2BP Bent flange tip
• 38033178016880: RA18-2BC Bent flange tip
• 38033178016873: RA18-1SP Straight collar tip
• 38033178016866: RA18-1SC Straight collar tip
• 38033178016859: RA24-1SC Straight collar tip
• 38033178016842: RA18-1BP Bent collar tip
• 38033178016835: RA24-2BP Bent flange tip
• 38033178016828: RA24-1SP Straight collar tip
• 38033178016811: RA24-2BB Bent flange tip
• 38033178016804: RA24-1SB Straight collar tip
• 38033178016798: RA18-2BB Bent flange tip
• 38033178016781: RA18-1SB Straight collar tip