Cardioplegia Plus

GUDID 30887691000301

Filters with Solution Spike

HAEMONETICS CORPORATION

Blood donor set, single-pack

• Primary Device ID: 30887691000301
• NIH Device Record Key: 5fcd5b7e-6fff-47d9-a7cf-c9b0c67f74ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardioplegia Plus
• Version Model Number: CPS02
• Company DUNS: 057827420
• Company Name: HAEMONETICS CORPORATION
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887691000307 [Primary]
GS1	30887691000301 [Package]; Contains: 10887691000307; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875095

FDA Product Code

• JOD: FILTER, BLOOD, CARDIOTOMY SUCTION LINE, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-19

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