BMR

GUDID 38033178114159

SORIN GROUP ITALIA SRL

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.