B-CAPTA

GUDID 38033178113114

SORIN GROUP ITALIA SRL

Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor

• Primary Device ID: 38033178113114
• NIH Device Record Key: bf0720e2-2bc7-4650-827e-891d793b986b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-CAPTA
• Version Model Number: 1/2" VENOUS CUVETTE
• 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	08033178113113 [Primary]
GS1	38033178113114 [Package]; Contains: 08033178113113; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202154

FDA Product Code

• DRY: MONITOR, BLOOD-GAS, ON-LINE, 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: 2021-05-13
• Device Publish Date: 2021-05-05

On-Brand Devices [B-CAPTA]

• 38033178113527: 3/8" ARTERIAL CUVETTE
• 38033178113510: 1/4" ARTERIAL CUVETTE
• 38033178113114: 1/2" VENOUS CUVETTE
• 38033178113107: 3/8" VENOUS CUVETTE
• 38033178113091: 1/4" VENOUS CUVETTE