AUTOTRANSFUSION ACCESSORIES

GUDID 38033178105560

SORIN GROUP ITALIA SRL

Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set

• Primary Device ID: 38033178105560
• NIH Device Record Key: 49ac362a-fc73-47d0-be5d-2061ea894402
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTOTRANSFUSION ACCESSORIES
• Version Model Number: BT277 (BRB1)
• 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	08033178105569 [Primary]
GS1	18033178105566 [Package]; Contains: 08033178105569; Package: BOX [10 Units]; In Commercial Distribution
GS1	38033178105560 [Package]; Contains: 18033178105566; Package: BOX [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872162

FDA Product Code

• CAC: APPARATUS, AUTOTRANSFUSION

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 ACCESSORIES]

• 38033178110151: VENTED WASTE BAG 10 LITERS
• 38033178105720: BRB-1
• 18033178105689: COD.150
• 18033178105610: COD. 151 E
• 38033178105591: BT845
• 38033178105560: BT277 (BRB1)
• 38033178105461: COD.150
• 38033178105447: BT696
• 38033178105430: BT697
• 38033178105478: COD. 131E