RESERVOIR

GUDID 38033178250314

SORIN GROUP ITALIA SRL

Cardiotomy reservoir

• Primary Device ID: 38033178250314
• NIH Device Record Key: 1aad97c8-9f3a-45d2-bf23-db5dd2d5d362
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESERVOIR
• Version Model Number: SYNTHESIS R + ADAPTORS
• 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	08033178250313 [Primary]
GS1	38033178250314 [Package]; Contains: 08033178250313; Package: BOX [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022450

FDA Product Code

• DTZ: OXYGENATOR, 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: 2020-01-22
• Device Publish Date: 2016-09-15

On-Brand Devices [RESERVOIR]

• 38033178250314: SYNTHESIS R + ADAPTORS
• 38033178250284: D970 DIDECO AVANT R
• 38033178250277: D754 DIDECO VENOMIDICARD
• 38033178250253: D764 DIDECO MIDICARD
• 38033178250222: D920 DIDECO LILLIPUT R
• 38033178250161: D744 D.A.C.
• 38033178250123: CARD 43 + ADAPTOR