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

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• Primary Device ID: 20814321020197
• NIH Device Record Key: f2a94d9b-6126-4876-af1d-dde071d6f0f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stableline Tubing Organizer (Non Sterile)
• Version Model Number: 5000N
• Company DUNS: 788403103
• Company Name: INTERNATIONAL BIOPHYSICS CORPORATION
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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	00814321020193 [Unit of Use]
GS1	20814321020197 [Primary]

FDA Product Code

• KRI: Accessory Equipment, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-07-15

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• 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