NexStat®

Technical Information

intended Use:

NexStat® Topical Hemostat Powder is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

Contraindications:

NexStat Topical Hemostat Powder should not be used on patients who have known allergies to potato starch.

Warnings:

• NexStat Topical Hemostat Powder is not intended as a substitute for appropriate standard of care procedures and meticulous surgical techniques.
• Care should be taken to avoid introduction of NexStat Topical Hemostat Powder into the airway during application.
• Do not inject powder into blood vessels as vessel occlusion could occur.
• The safety and efficacy of NexStat Topical Hemostat Powder in combination with other hemostatic devices has not been clinically evaluated and is therefore not recommended.
• Contains potato starch

Precautions:

• Carefully read the Instructions for use prior to application.
• Single Use Only.
• Sterility not guaranteed if package is damaged or opened. Discard damaged or open packages.
• Expiration Date: This device should not be used after the end of the year and month shown.
• The flexible applicator tips are supplied along with the NexStat Topical Hemostat bellows dispenser as a sterile (single use only) product and cannot be re-sterilized.
• To prevent product contamination prior to application, always follow aseptic techniques.
• If the flexible tip becomes clogged with blood, remove tip, discard and replace with new tip. NexStat Hemostat Powder is supplied with 3 sterile tips.

Instructions:

1. Peel open pouch to remove contents. NexStat Topical Hemostat Powder
2. Remove cap from applicator. Discard cap.
3. Insert one flex tip into applicator.
4. Remove excess blood from the wound site.
5. Apply NexStat Topical Hemostat Powder in a sufficient amount to cover wound. Note: If the flexible tip becomes clogged with blood, remove tip, discard and replace with new tip.
6. Use a gauze pad to cover the powder once it has been applied on the wound site and hold in place. Periodically check the site to ensure that hemostatic control has been achieved.
7. To remove the gauze pad, soak the gauze pad using sterile water and gently remove from the wound site and verify hemostasis.
8. If hemostasis has not been achieved, repeat the above steps until hemostasis has been achieved or use an alternate method of hemostasis treatment.
9. NexStat Topical Hemostat Powder leaves the site of placement by natural elimination, or it may be aspirated from the application site at the direction of the physician.
10. Discard any unused product after opening.

Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. For detailed information regarding indications for use, warnings and precautions, see Instructions for Use.

Content taken from 50035 Rev. C