FloPump 6400N

GUDID 00814321020148

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

• Primary Device ID: 00814321020148
• NIH Device Record Key: 23a308b6-2baf-46b9-aae6-bc635df78077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloPump
• Version Model Number: 6400N
• Catalog Number: 6400N
• 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	00814321020148 [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: true
• Device Is Sterile: false

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

[00814321020148]

Ethylene Oxide

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