IBC Suction Wand (Non Sterile)

GUDID 10814321020374

The IBC Suction Wand is a component of Blood Recovery Suction Systems for use in open heart procedures, autologus blood recovery or blood suction. It is a disposable, single use component.

INTERNATIONAL BIOPHYSICS CORPORATION

Surgical/emergency suction cannula, non-illuminating, single-use
Primary Device ID10814321020374
NIH Device Record Key61ce641a-2a4f-41be-9197-9c1c561c5fc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameIBC Suction Wand (Non Sterile)
Version Model Number1990N
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
GS100814321020377 [Unit of Use]
GS110814321020374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


[10814321020374]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-04-20
Device Publish Date2016-07-11

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, 2.8mm2021-12-14 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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