Sarns™ Centrifugal Pump Adapter

GUDID 00699753450417

Terumo Cardiovascular Systems Corporation

Pin-indexed adaptor, reusable Pin-indexed adaptor, reusable

• Primary Device ID: 00699753450417
• NIH Device Record Key: 4d00dfc2-0eb9-456a-bd3f-3063c68e6ad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sarns™ Centrifugal Pump Adapter
• Version Model Number: 824043
• Company DUNS: 177655466
• Company Name: Terumo Cardiovascular Systems 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: false
• 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	00699753450417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112229

FDA Product Code

• KFM: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

Devices Manufactured by Terumo Cardiovascular Systems Corporation

• 50699753531210 - Cardiovascular Procedure Kit: 2024-04-19
• 50699753531227 - Cardiovascular Procedure Kit: 2024-04-19
• 50699753531234 - Cardiovascular Procedure Kit: 2024-04-19
• 50699753531180 - Cardiovascular Procedure Kit: 2024-04-18
• 00699753531192 - Cardiovascular Procedure Kit: 2024-04-18
• 00699753531208 - Cardiovascular Procedure Kit: 2024-04-18
• 50699753531104 - Cardiovascular Procedure Kit: 2024-04-15
• 50699753531111 - Cardiovascular Procedure Kit: 2024-04-15