INTERNATIONAL BIOPHYSICS CORPORATION

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Accessory Equipment, Cardiopulmonary Bypass (KRI) (2) Instruments, Surgical, Cardiovascular (DWS) (2) Sucker, Cardiotomy Return, Cardiopulmonary Bypass (DTS) (2) Non-Surgical Isolation Gown (OEA) (1)

Premarket Exempt

No Yes

Clear

IBC Aortic Punch, Medium, 5.6mm - 10814321020350 Catalog Number :

Device Description : The IBC Aortic Punch is a single use, disposable, surgical punch to be used to c 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 prepare a site for anastomosis.

Device Class :

Duns Number: 788403103

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 10

IBC Aortic Punch, Medium, 6.0mm - 10814321020367 Catalog Number :

Device Class :

Duns Number: 788403103

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 10

IBC Suction Wand (Non Sterile) - 10814321020374 Catalog Number :

Device Description : The IBC Suction Wand is a component of Blood Recovery Suction Systems for use in 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.

Device Class :

Duns Number: 788403103

Premarket Exempt : No

Product Code : DTS

Prescription Use : Yes

Device Count : 10

IBC Tubing Organizer (Non Sterile) - 10814321020398 Catalog Number :

Device Description : The Tubing Organizer is designed to stabilize and contain one to six tubing line 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.

Device Class :

Duns Number: 788403103

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : Yes

Device Count : 10

IBC Mini Sucker (Non Sterile) - 10814321020411 Catalog Number :

Device Description : The IBC Mini Sucker is a component of Blood Recovery Suction Systems for use in The IBC Mini Sucker 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.

Device Class :

Duns Number: 788403103

Premarket Exempt : No

Product Code : DTS

Prescription Use : Yes

Device Count : 10

AffloShield - 10814321020466 Catalog Number : 8600

Device Description : The AffloShield is a disposable gown intended for use with the AffloVest product line.

Device Class :

Duns Number: 788403103

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

Stableline Tubing Organizer (Non Sterile) - 20814321020197 Catalog Number :

Device Description : The Stableline is designed to stabilize and contain one to six tubing lines of v 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.

Device Class :

Duns Number: 788403103

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : Yes

Device Count : 25

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