FloPump 6400S

GUDID 00814321020131

The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

INTERNATIONAL BIOPHYSICS CORPORATION

Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 00814321020131
• NIH Device Record Key: 39aa32bb-0c45-4999-82bd-f46915678f6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloPump
• Version Model Number: 6400S
• Catalog Number: 6400S
• Company DUNS: 788403103
• Company Name: INTERNATIONAL BIOPHYSICS 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814321020131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170029

FDA Product Code

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

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: 2017-12-18

On-Brand Devices [FloPump]

• 00814321020148: The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to
• 00814321020131: The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to
• 00814321020124: The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th
• 00814321020117: The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th
• 00814321020100: The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th
• 00814321020094: The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th
• 00814321020018: The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th
• 00814321020001: The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th
• 00814321020452: The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th
• 00814321020445: The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to
• 00814321020438: The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to