FloProbe 1/4’’ x 1/4’’ (Sterile)

GUDID 00814321020162

The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.

INTERNATIONAL BIOPHYSICS CORPORATION

Electromagnetic blood flowmeter

• Primary Device ID: 00814321020162
• NIH Device Record Key: e31aa8c7-8e72-49e9-882a-c41ba66fd634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloProbe 1/4’’ x 1/4’’ (Sterile)
• Version Model Number: 3090S
• 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	00814321020162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963703

FDA Product Code

• DPT: Probe, Blood-Flow, Extravascular

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: 2016-07-12

Devices Manufactured by INTERNATIONAL BIOPHYSICS CORPORATION

• 10814321020152 - FloProbe 1/4’’ x 1/4" (Non Sterile): 2021-12-15 The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjun
• 10814321020176 - FloProbe 3/8’’ x 3/8” (Non Sterile): 2021-12-15 The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjun
• 10814321020213 - IBC Aortic Punch, Long, 2.8mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to
• 10814321020220 - IBC Aortic Punch, Long, 3.6mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to
• 10814321020237 - IBC Aortic Punch, Long, 4.0mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to
• 10814321020244 - IBC Aortic Punch, Long, 4.4mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to
• 10814321020251 - IBC Aortic Punch, Long, 4.8mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to
• 10814321020268 - IBC Aortic Punch, Long, 5.2mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to