Stableline Tubing Organizer (Non Sterile)

GUDID 20814321020197

The Stableline 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 ID20814321020197
NIH Device Record Keyf2a94d9b-6126-4876-af1d-dde071d6f0f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameStableline Tubing Organizer (Non Sterile)
Version Model Number5000N
Company DUNS788403103
Company NameINTERNATIONAL BIOPHYSICS CORPORATION
Device Count25
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
GS100814321020193 [Unit of Use]
GS120814321020197 [Primary]

FDA Product Code

KRIAccessory Equipment, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


[20814321020197]

Ethylene Oxide


Device Entry Metadata

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

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