FloPump 6000S(KIT)

GUDID 00814321020094

The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.

INTERNATIONAL BIOPHYSICS CORPORATION

Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 00814321020094
• NIH Device Record Key: b4a4c9b3-be65-49a8-b4c3-2946126a1602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloPump
• Version Model Number: FloPump/FloProbe Kit (Sterile)
• Catalog Number: 6000S(KIT)
• 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: true
• 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	00814321020094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983272

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: 2015-10-20

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