AUTOTRANSFUSION ACCESSORIES

GUDID 38033178105461

SORIN GROUP ITALIA SRL

Red blood cell-recovery autotransfusion system set

• Primary Device ID: 38033178105461
• NIH Device Record Key: 3e048391-17ee-43d6-9d78-04dd4ccbe87b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTOTRANSFUSION ACCESSORIES
• Version Model Number: COD.150
• 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	08033178105460 [Primary]
GS1	18033178105467 [Package]; Contains: 08033178105460; Package: BOX [8 Units]; In Commercial Distribution
GS1	38033178105461 [Package]; Contains: 18033178105467; Package: BOX [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963758

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