AUTOTRANSFUSION RESERVOIR

GUDID 38033178105393

SORIN GROUP ITALIA SRL

Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container

• Primary Device ID: 38033178105393
• NIH Device Record Key: a7044483-be5e-4962-9b5e-e8e5a83311f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTOTRANSFUSION RESERVOIR
• Version Model Number: BT844 + EXTENSION LINE
• 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	08033178105392 [Primary]
GS1	38033178105393 [Package]; Contains: 08033178105392; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884872

FDA Product Code

• DTN: RESERVOIR, BLOOD, 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: 2021-01-08
• Device Publish Date: 2015-07-15

On-Brand Devices [AUTOTRANSFUSION RESERVOIR]

• 38033178105393: BT844 + EXTENSION LINE
• 38033178105386: BT844 + CYA
• 38033178105379: BT894 + CYA