BMR

GUDID 38033178114159

SORIN GROUP ITALIA SRL

Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir

• Primary Device ID: 38033178114159
• NIH Device Record Key: 87b884e0-eb80-49f5-9f35-837d70dd95bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BMR
• Version Model Number: 1900 PH.I.S.I.O.
• 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: true
• 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	08033178114158 [Primary]
GS1	38033178114159 [Package]; Contains: 08033178114158; Package: BOX [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223361

FDA Product Code

• DTN: Reservoir, blood, cardiopulmonary bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-13
• Device Publish Date: 2023-10-05

On-Brand Devices [BMR]

• 38033178250383: 1900 PH.I.S.I.O.
• 38033178109551: 1900L PH.I.S.I.O.
• 08033178114165: 1900L PH.I.S.I.O.
• 38033178114159: 1900 PH.I.S.I.O.