AUTOTRANSFUSION RESERVOIR

GUDID 38033178105393

SORIN GROUP ITALIA SRL

Red blood cell-recovery autotransfusion system 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