IBC Tubing Organizer (Sterile)

GUDID 00814321020407

The Tubing Organizer is designed to stabilize and contain one to six tubing lines of varying sizes which connect cardiopulmonary bypass equipment for delivery or return of fluids to and from the surgical field. The product attaches to the surgical drapes and prevents the tubing lines from slipping, while keeping them out of the way of appropriate procedures. This component is a disposable, single use item.

INTERNATIONAL BIOPHYSICS CORPORATION

Medical/surgical interventional tube/cable securement clip, single-use
Primary Device ID00814321020407
NIH Device Record Key3ba3a018-8398-4f2a-acff-3de6c80b6073
Commercial Distribution StatusIn Commercial Distribution
Brand NameIBC Tubing Organizer (Sterile)
Version Model Number5020S
Company DUNS788403103
Company NameINTERNATIONAL BIOPHYSICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100814321020407 [Primary]

FDA Product Code

KRIAccessory Equipment, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-12-11
Device Publish Date2016-07-15

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.