FloProbe 1/4’’ x 1/4" (Non Sterile)

GUDID 10814321020152

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 ID10814321020152
NIH Device Record Key6f7d0b02-0422-42bf-8d31-81711ccabe02
Commercial Distribution Discontinuation2021-12-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFloProbe 1/4’’ x 1/4" (Non Sterile)
Version Model Number3090N
Company DUNS788403103
Company NameINTERNATIONAL BIOPHYSICS CORPORATION
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814321020155 [Unit of Use]
GS110814321020152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPTProbe, Blood-Flow, Extravascular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


[10814321020152]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-12-15
Device Publish Date2016-07-12

Devices Manufactured by INTERNATIONAL BIOPHYSICS CORPORATION

10814321020152 - FloProbe 1/4’’ x 1/4" (Non Sterile)2021-12-15The 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.
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, 2.8mm2021-12-14 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, 3.6mm2021-12-14 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, 4.0mm2021-12-14 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, 4.4mm2021-12-14 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, 4.8mm2021-12-14 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, 5.2mm2021-12-14 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

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