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TISSEEL VH [FIBRIN SEALANT] KIT WITH DUPLOJECT SYSTEM

Provides all components for reconstitution and delivery of fibrin sealant. Each TISSEEL VH with DUPLOJECT System contains one DUPLOJECT applicator, two joining pieces, four application cannula tips, four syringes and four needles. Available in three kit sizes.

1 mL Kit ­ 921028 2 mL Kit ­ 921029 5 mL Kit ­ 921030

TISSEEL VH [FIBRIN SEALANT] VALUPAK

A combined offering of the DUPLOJECT EASY PREP System and TISSEEL VH Biologic-only. VALUPAK is configured as a dual six-pack, available in three sizes.

1 mL ­ 921051VP 2 mL ­ 921052VP 5 mL ­ 921053VP

Note: Electronic Customers Only: If ordering VALUPAK electronically, you will need to use two product codes. (The second number is the corresponding EasyPrep component code and will be listed as "no charge" on your invoice.) 1 mL ­ 921051VP and 921063VP 2 mL ­ 921052VP and 921064VP 5 mL ­ 921053VP and 921065VP

Please see accompanying Full Prescribing Information. Please see Important Safety Information on page 13.

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To order, call 1-800-423-2090

DUPLOJECT EASY PREP SYSTEM

Simplifies the transfer of components to the sterile field eliminating needle interface. The DUPLOJECT EASY PREP System contains the QUIK-FILL device, pre-assembled DUPLOJECT syringe and two transfer devices. Available in cases of six.

1 mL ­ 921063 2 mL ­ 921064 5 mL ­ 921065

FIBRINOTHERM DEVICE ­ 921025

The FIBRINOTHERM heating and stirring device helps automate the reconstitution of TISSEEL VH [Fibrin Sealant]. Optimal physiologic temperature is maintained for short-term storage (up to 4 hours).

DUOFLO MANUAL SPRAY SET ­ 921023

A versatile delivery option that dispenses TISSEEL VH via a homogenous fine spray without the necessity of pressurized gas. Sold individually.

Please see accompanying Full Prescribing Information. Please see Important Safety Information on page 13.

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To order, call 1-800-423-2090

EASYSPRAY PRESSURE REGULATOR ­ 0600012

A control unit that uses pressurized gas for uniform spray delivery. The EASYSPRAY enables an aerosolized spray application at the control of the surgeon's fingertips. The EASYSPRAY device is to be used only with spray sets specified for use with this pressure regulator.

EASYSPRAY SET ­ 0600013

A disposable set consisting of a dual-lumen connector hose, a sterile filter, two spray heads, and a clip to be attached to the DUPLOJECT plunger for gas activation. The EASYSPRAY delivers a thin, uniform film of fibrin sealant over wound surfaces. Surface coverage area is up to 100 cm2 per mL of fibrin sealant versus 8 cm2 with a cannula. Spray set is designed for use with the EASY SPRAY Pressure Regulator. Available in cases of ten.

TISSOMAT SPRAY SET ­ 921031

A disposable set consisting of a connector hose, sterile filter and two spray heads. Delivers a thin, uniform film of fibrin sealant over wound surfaces. Surface coverage area is approximately 100 cm2 per mL of fibrin sealant verses 8 cm2 with a cannula. For use with DUPLOJECT applicator and TISSOMAT Pressure Control Device. Available in cases of ten.

Please see accompanying Full Prescribing Information. Please see Important Safety Information on page 13.

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To order, call 1-800-423-2090

DUPLOCATH APPLICATION CATHETERS

Various catheter options are available to assist in the delivery of TISSEEL VH [Fibrin Sealant]. All of these catheters work with the DUPLOJECT application device and may be substituted for the standard cannula. Available as single, disposable units.

DEVICE

LENGTH

DIAMETER

DEAD VOLUME

5

921022

DUPLOCATH 25 Application Catheter

25 cm

0.17 cm

0.12 mL/lumen

921020

DUPLOCATH 35 M.I.S. Application Catheter

35 cm

0.17 cm

0.17 mL/lumen

Insertion is through a 5-6 mm trocar for minimally invasive surgery (M.I.S.) Includes one catheter and one M.I.S. adapter.

921021

DUPLOCATH 180 Application Catheter

180 cm

0.17 cm

0.87 mL/lumen

Extra-long tubing is designed for endoscopic application.

Catheter dimensions are approximate.

DUPLOREACH 35 EXTENDED APPLICATOR ­ 921050

An extended applicator, pre-assembled for immediate use, to assist in the delivery of TISSEEL VH. This disposable device is packaged with two radiopaque replacement spray tips. The 35 mm stainless steel sleeve provides rigidity. Available in cases of six. Please see accompanying Full Prescribing Information. Please see Important Safety Information on page 13.

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To order, call 1-800-423-2090

FIBRIJET DUPLOTIP APPLICATORS

Malleable dual cannula tips specifically adapted for use with the DUPLOJECT applicator for precise delivery of TISSEEL VH [Fibrin Sealant] to small areas or deep surgical sites. Available as single, disposable units.

DEVICE

921042

FIBRIJET 57 DUPOLTIP Applicator

LENGTH

57 mm (2.25 in)

DIAMETER

26 gauge dual cannula

DEAD VOLUME

0.009 mL/lumen

921043

FIBRIJET 83 DUPLOTIP Applicator

83 mm (3.25 in)

26 gauge dual cannula

0.012 mL/lumen

921044

FIBRIJET 51 DUPLOTIP Applicator

51 mm (2 in)

20 gauge dual cannula

0.047 mL/lumen

921045

FIBRIJET 102 DUPLOTIP Applicator

101 mm (4 in)

20 gauge dual cannula

0.067 mL/lumen

921046

FIBRIJET 267 DUPLOTIP Applicator

267 mm (10.25 in)

20 gauge dual cannula

0.171 mL/lumen

921047

FIBRIJET 318 DUPLOTIP Applicator

Tip dimensions are approximate.

318 mm (12 in)

5 mm

(fits 5 mm diameter sleeve)

0.27 mL/lumen

Please see accompanying Full Prescribing Information. Please see Important Safety Information on page 13.

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To order, call 1-800-423-2090

FLOSEAL [HEMOSTATIC MATRIX] ­ 934057

Provides all components for mixing and delivery of FLOSEAL [Hemostatic Matrix]. Each FLOSEAL kit contains a gelatin matrix component, a thrombin component, a luer connector syringe, a small bowl and 2 applicator tips. FLOSEAL can be stored up to 25º C. Available in cases of six.

FLOSEAL NT [HEMOSTATIC MATRIX] ­ 934050

Provides FLOSEAL components for mixing and delivery of the surgical hemostat, minus the thrombin. Each FLOSEAL kit contains a gelatin matrix component, a luer connector syringe, a small bowl and 2 applicator tips. FLOSEAL can be stored up to 25º C. Available in cases of six.

Please see accompanying Instructions For Use. Please see Important Safety Information on page 13.

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To order, call 1-800-423-2090

CURVED APPLICATOR

Stainless steel applicator tips for the delivery of FLOSEAL [Hemostatic Matrix] allow easy access to challenging anatomy. May be sterilized for reuse.

DEVICE

LENGTH

934208

Curved Applicator Tip

8 cm

934210

Curved Applicator Tip

10 cm

ENDOSCOPIC APPLICATOR (REUSABLE)

A re-usable applicator to deliver hemostatic agents to minimally invasive surgical sites. Consists of two components; one non-reflective stainless steel cannula and one stainless steel stylet.

DEVICE 934055

Endoscopic Applicator (Reusable)

LENGTH

DIAMETER

292 mm

5 mm

Please see accompanying Instructions For Use. Please see Important Safety Information on page 13.

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To order, call 1-800-423-2090

FLOSEAL ENDOSCOPIC APPLICATOR (STERILE/SINGLE USE) ­ 1500181

A sterile, single use device designed for delivering FLOSEAL [Hemostatic Matrix] to bleeding surgical sites through a 5 mm or larger trocar. The Endoscopic Applicator consists of two components: a non-reflective stainless steel cannula and a stainless steel stylet (obturator). Available in cases of six.

Please see accompanying Instructions For Use. Please see Important Safety Information on page 13.

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To order, call 1-800-423-2090

COSEAL [SURGICAL SEALANT]

Provides all components for mixing and delivery of COSEAL [Surgical Sealant]. Each COSEAL kit contains a two-liquid component preloaded in delivery housing, one powder component and two applicator tips. COSEAL can be stored at room temperature (up to 25º C). Available in three kit sizes.

2 mL ­ 934070 4 mL ­ 934071 8 mL ­ 934072

Please see accompanying Instructions For Use. Please see Important Safety Information on page 13.

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To order, call 1-800-423-2090

APPLICATORS FOR COSEAL [SURGICAL SEALANT]

Disposable and malleable, dual lumen devices for precise delivery of COSEAL [Surgical Sealant] to small areas or deep surgical sites.

DEVICE

LENGTH

QUANTITY

934033

Replacement applicator

7 cm

case of 5

934034

Extended applicator

22 cm

case of 10

Please see accompanying Instructions For Use. Please see Important Safety Information on page 13.

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To order, call 1-800-423-2090

OTHER DEVICES SPRAY ACCESSORY KIT ­ 934500

A disposable set consisting of tubing and one spray head. For use with COSEAL [Surgical Sealant] syringe and air regulator. Available in cases of five.

Please see accompanying Instructions For Use. Please see Important Safety Information on page 13.

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To order, call 1-800-423-2090

TISSEEL VH [Fibrin Sealant] Indications TISSEEL VH is indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by conventional surgical techniques, including suture, ligation and cautery, is ineffective or impractical. TISSEEL VH is not indicated for the treatment of massive and brisk arterial or venous bleeding. TISSEEL VH has been shown to be an effective sealant as an adjunct in the closure of colostomies. TISSEEL VH is a satisfactory hemostatic agent in fully heparinized patients undergoing cardiopulmonary bypass. Important Safety Information TISSEEL VH is contraindicated in individuals who are known to be hypersensitive to bovine protein. To avoid risk of allergic-anaphylactoid reaction and/or thromboembolic events, which may be life threatening, TISSEEL VH should not be injected intravascularly or into tissue. Especially in coronary bypass surgery, TISSEEL VH should be applied with caution to minimize any risk of intravascular application. As with all human plasmaderived therapeutics, the potential to transmit infectious agents, such as viruses, cannot be totally eliminated.

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FLOSEAL [Hemostatic Matrix] Indications FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. FLOSEAL is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis. Important Safety Information FLOSEAL must not be injected into blood vessels, or allowed to enter blood vessels. Extensive intravascular clotting and even death may result. Do not use FLOSEAL in patients with known allergies to material of bovine origin. As with all human plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses, cannot be totally eliminated. The maximum swell volume of approximately 20% is achieved within about 10 minutes. Excess FLOSEAL (material not incorporated in the hemostatic clot) should be removed by gentle irrigation from the site of application.

COSEAL [Surgical Sealant] Indications COSEAL is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. Important Safety Information COSEAL is not to be used in place of sutures, staples, or mechanical closure. Do not inject COSEAL into vessels. There are no known contraindications for this device. In vivo testing demonstrated a mild skin sensitization response in an animal model. Similar testing in humans has not been conducted. COSEAL swells up to four times its volume within 24 hours of application and additional swelling may occur as the gel resorbs. Maximum swell volume should be considered around areas sensitive to compression.

Please see accompanying Full Prescribing Information and Instructions For Use.

For orders please contact your Baxter representative or call 1-800-423-2090

Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015

www.advancingbiosurgery.com

BAXTER, EASYSPRAY, FLOSEAL, EASY PREP, QUIK-FILL, DUPLOCATH and DUPLOREACH are trademarks of Baxter International Inc. TISSEEL, FIBRINOTHERM, DUPLOJECT, TISSOMAT, and DUPLOTIP are trademarks of Baxter AG. BAXTER, FLOSEAL DUPLOCATH, DUPLOREACH, TISSEEL, FIBRINOTHERM, DUPLOJECT, and TISSOMAT are registered in the U.S. Patent and Trademark Office. COSEAL is a registered trademark of Angiodevice International Gmbh. FIBRIJET is a registered trademark of Micromedics, Inc. DUOFLO is a registered trademark of Hermaedics, Inc. BS1118 44075 10/05

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