B-CAPTA

GUDID 38033178113527

SORIN GROUP ITALIA SRL

Cardiopulmonary bypass system blood gas sensor

• Primary Device ID: 38033178113527
• NIH Device Record Key: 06fc64a2-1fa4-4f47-b93e-e9f0d8f5e920
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-CAPTA
• Version Model Number: 3/8" ARTERIAL 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	08033178113526 [Primary]
GS1	38033178113527 [Package]; Contains: 08033178113526; 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