Frequently Asked Questions - OMNI-STAT®

This page is designed to help address and answer Frequently Asked Questions (FAQs) about our products and provide additional details. Please do not hesitate to reach out to us directly with questions at (646) 417-8452 or at info@omni-stat.com.

1.

What is OMNI-STAT®?

OMNI-STAT® is a very effective hemostat agent optimized to stop bleeding fast. It is made of a proprietary composition which contains chitosan. Chitosan is a natural polymer extracted from shrimp shells and highly purified. The OMNI-STAT® composition is protected by 3 patents within the US.

2.

How does OMNI-STAT work to stop bleeding?

OMNI-STAT® hemostatic granules are very high surface area flakes. When they come in contact with blood, OMNI-STAT® swells, gels, and sticks together to make a gel like clot, without generating any heat. It works independently of the body’s normal clotting mechanism, works in hypothermic conditions and clots blood containing the blood-thinning drug heparin1. More about how OMNI-STAT® hemostatic agents work can be found at www.omni-stat.com.

3.

Can OMNI-STAT be left inside the body?

No. OMNI-STAT® is for topical temporary external use only.

4.

Where can I get the product?

OMNI-STAT® is cleared for sale in the US for use under the supervision of a healthcare professional. For information on ordering OMNI-STAT® please contact your sales representative or you can reach us at info@omni-stat.com for additional details.

Ordering details

  • FG04530401    OMNI-STAT®  Hemostatic granules 0.1oz (3g )  – 15 pouches/carton
  • FG07730531    OMNI-STAT®  Hemostatic granules 0.1oz (3g ) with exterior pouch – 10 pouches/carton
  • FG04530411    OMNI-STAT®  Hemostatic gauze 4in x 4in (10.2cm x 10.2cm) pad – 10 pouches/carton
  • FG07734331    OMNI-STAT®  Hemostatic gauze 2/3in x 4 3/4in (17mm x 120mm) pad – 10 pouches/carton
  • FG08838021    CELOX Gauze 3in x 5ft Z-Fold (7.6cm x 1.5m) – 10 pouches/carton

  • FG08832071A  CELOX-A 0.2oz (6g) Applicator – 10 pouches/carton

  • FG08834081    CELOX Vascular 2in x 2in (51mm x 51mm) – 10 pouches/carton

To find out more about OMNI-STAT®, please contact info@omni-stat.com with details about your intended use.

5.

Is OMNI-STAT a Pharmaceutical?

No. OMNI-STAT® is classified and regulated by the FDA as an unclassified Medical Device.

6.

Is OMNI-STAT cleared for sale in the US?

Yes, OMNI-STAT® is cleared under several 510Ks.

7.

Will OMNI-STAT stop severe bleeding?

Yes, OMNI-STAT® includes an indication for use under the supervision of a healthcare professional for topical temporary external treatment for controlling moderate to severe bleeding.

8.

Will OMNI-STAT clot blood containing anticoagulants such as Coumadin or Heparin?

Yes, OMNI-STAT® has been tested and shown to clot blood containing warfarin (Coumadin) and heparin1.

9.

Will OMNI-STAT clot hypothermic blood?

Yes, it will stop bleeding in cold conditions. OMNI-STAT® has been tested and proven to clot blood as cool as 56° Fahrenheit1.

10.

How is OMNI-STAT applied?

OMNI-STAT 3 (g) Granules

  • Tear open the OMNI-STAT® 3g pouch
  • Blot away any excess blood or exudate from the wound
  • Pour enough OMNI-STAT® onto the wound to cover the entire bleeding area. OMNI-STAT® should be applied directly to the source of the bleeding
  • Quickly cover with gauze and apply firm pressure for 1 to 3 minutes depending on the severity of the bleeding.
  • If bleeding continues apply pressure for 3 more minutes. If further OMNI-STAT® is required use an additional pouch.
  • Five minutes after bleeding has stopped, gently remove any excess OMNI-STAT®. Use saline if required
  • Discard any unused OMNI-STAT®

OMNI-STAT 3 (g) Granules with exterior pouch

  • Peel open OMNI-STAT® outer pouch and remove inner pouch
  • Tear open OMNI-STAT® inner pouch.
  • Blot away any excess blood or exudate from the wound.
  • Pour enough OMNI-STAT® onto the wound to cover the entire bleeding area. OMNI-STAT® should be applied directly to the source of bleeding.
  • Quickly cover with gauze and apply firm pressure for 1 to 3 minutes depending on the severity of the bleeding.
  • If bleeding continues apply pressure for 3 more minutes. If further OMNI-STAT® is required use an additional pouch.
  • Five minutes after bleeding has stopped, gently remove any excess OMNI-STAT®. Use saline if required.
  • Discard any unused granules after opening.

OMNI-STAT 4in x 4in Gauze

  • Tear open the OMNI-STAT® gauze pack
  • Blot away any excess blood or exudate from the wound
  • Apply pre-folded OMNI-STAT® onto the wound to cover the entire bleeding area. OMNI-STAT® should be applied directly to the source of the bleeding. If bleeding is below the wound surface, then OMNI-STAT® gauze can be unfolded and tightly packed into the wound.
  • Apply firm pressure for 1 to 3 minutes depending on the severity of the bleeding.
  • If bleeding continues apply pressure for 3 more minutes. If OMNI-STAT® gauze becomes saturated then use an additional OMNI-STAT® gauze pack.
  • OMNI-STAT® gauze can be gently removed after 5 minutes Use saline if required
  • Discard any unused OMNI-STAT®

OMNI-STAT 2/3in x 4 3/4in Gauze

  • Peel open pouch and remove the folded gauze from pack
  • Blot away any excess blood or exudate from the wound
  • Apply pre-folded OMNI-STAT® hemostatic gauze directly to the source of bleeding
  • Apply firm pressure for 1-3 minutes depending on severity of the bleeding.If bleeding continues apply firm pressure for a further 3 minutes. If gauze becomes saturated additional
    OMNI-STAT® hemostatic gauze can be used if required
  • OMNI-STAT® hemostatic gauze can be gently removed after 5 minutes. If necessary, use water or saline on the pad before removal.
  • Discard any unused gauze after opening.

11.

Can OMNI-STAT be easily removed from a wound?

Yes – Five minutes after bleeding has stopped, gently remove any excess OMNI-STAT®. Use saline if required.

Granules – OMNI-STAT® should be cleansed and removed from the wound using your standard wound cleansing protocol. If required OMNI-STAT® can be removed (physically) and then any residual irrigated away with water or saline.

Gauze pad – OMNI-STAT® should be cleansed and removed from the wound using your standard wound cleansing protocol. If required OMNI-STAT® should be soaked with saline prior to removal (physically) and then any residual irrigated away with water or saline.

12.

What shelf life does OMNI-STAT have?

OMNI-STAT® has a 3 year shelf life from the manufacturing date. We have tested and proven that OMNI-STAT® will still pass its original specification after 3 years of aging.

13.

Can I use OMNI-STAT past its shelf life?

No. The efficacy of OMNI-STAT® products cannot be guaranteed past the expiry date found on the packaging.

14.

Is OMNI-STAT suitable to stop bleeding on minor wounds?

OMNI-STAT® is cleared for minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures and also for, moderate and severe bleeding.

15.

Does OMNI-STAT generate heat?

No, OMNI-STAT® hemostatic products do not generate heat. OMNI-STAT® has been independently tested and shown not to generate any increase in heat during blood clotting.

16.

Are there any contraindications?

OMNI-STAT® is not intended for internal use. OMNI-STAT® should not be used in the eyes. It is not indicated for use in the mouth.

17.

What happens if I get OMNI-STAT granules in my eyes?

Do not apply OMNI-STAT® over eyes. If eye irritation occurs, flush the eyes with water for 5 minutes and repeat if irritation continues. OMNI-STAT® absorbs moisture when in contact with fluid and can absorb moisture from the surface of the eyes which causes irritation.

18.

Do people with shellfish allergies have allergic reactions to OMNI-STAT as a result of the chitosan?

There have been no known or suspected allergic reactions as a result of using OMNI-STAT® since its launch in 2006. The chitosan has been extensively tested on individuals with suspected and confirmed shellfish allergy, none of the test subjects demonstrated any dermal sensitivity when tested against the chitosan material.

19.

What happens if I accidentally consume OMNI-STAT?

Do not eat. OMNI-STAT® is not recommended for consumption. OMNI-STAT® absorbs moisture when in contact with fluid and can absorb moisture from the gut which may cause discomfort.

If ingested, drink copious amounts of water to avoid any discomfort.

20.

Is OMNI-STAT a powder?

No, OMNI-STAT® granules are macroscopic granular flakes prepared from Chitosan, a material derived from Chitin which is found naturally in crustacean exoskeleton or shell.

21.

How do I store OMNI-STAT?

OMNI-STAT® products should be stored in the unopened pouch in dry conditions at ambient temperature and no special storage conditions are required or indicated on the product labelling.
Discard any remaining product after use as sterility will be compromised.
Reuse could potentially pose a risk of infection.

22.

How many times can you use OMNI-STAT to treat wounds and how many wounds?

OMNI-STAT® products are provided sterile for single use. OMNI-STAT® can be used to treat several wounds on one casualty. Do not store unused opened packs of OMNI-STAT® for later use. Products sterility and performance may be affected.

23.

Can I use OMNI-STAT on the Head or Neck?

OMNI-STAT® can be used externally on the head and neck. Refer to your clinical guidelines and or training, for example: Treatment of injuries in these areas needs to consider the airway and major blood vessels that supply the brain and the risk of applying pressure to the brain and nervous tissue in the event of a fracture. OMNI-STAT® is not approved for use inside of the mouth or on eyes.


References: 1. Data on File Omni-stat Medical Inc

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Omni-stat Medical Inc

New York – SoHo – Hudson Square,
101 Avenue of the Americas,
8th and 9th Floors,
New York, NY 10013,
USA

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