NAME OF THE MEDICAL DEVICE
“GEMOVIS” Hemostatic Sterile Gel for Single Topical Use, in accordance with TU 21.20.24‑001‑03852034‑2023, in the following versions:
— “GEMOVIS” Hemostatic Sterile Gel for Single Topical Use in stand‑up pouch bags (doypacks) with volumes of 60 ml, 80 ml, and 110 ml;
— “GEMOVIS” Hemostatic Sterile Gel for Single Topical Use in corrugated bottles with applicator with volumes of 10 ml, 35 ml, 65 ml, 85 ml, and 110 ml;
— “GEMOVIS” Hemostatic Sterile Gel for Single Topical Use in thick syringes with volumes of 20 ml; gel volume in the syringe is 10 ml, 15 ml, and 20 ml;
— “GEMOVIS” Hemostatic Sterile Gel for Single Topical Use in thin syringes with a volume of 10 ml; gel volume in the syringe is 5 ml and 10 ml.
Instructions for use – 1 copy per transport packaging.

INFORMATION ABOUT THE MEDICAL DEVICE MANUFACTURER
Developer and manufacturer: LLC “Vavi Pharm”.
Legal address: 197183, Saint‑Petersburg, Sabirovskaya Street, 50, building A, rooms 106 and 15‑N, office 403A.

INTENDED PURPOSE OF THE MEDICAL DEVICE, AS ESTABLISHED BY THE MANUFACTURER
For stopping external bleeding of various intensity, mainly at the pre‑hospital stage, in field conditions, as well as in combat‑zone areas. The gel is intended only for local (external) use.

USE CONDITIONS
Field of application:
In external bleeding at the pre‑hospital stage, in field conditions, as well as in disaster and combat‑zone areas.
Potential users:
Medical personnel, patients, military personnel.

OPERATING ENVIRONMENT CONDITIONS
The gel must be resistant to climatic factors in accordance with GOST 15150 for climatic category U1 during operation.

RISKS OF USING THE MEDICAL DEVICE, LIST OF INDICATIONS, CONTRAINDICATIONS, AND POSSIBLE ADVERSE EFFECTS
Indications for use:
The gel is used to stop local external mixed‑type bleeding of various intensity, mainly at the pre‑hospital stage, in field conditions.
Contraindications:
Individual intolerance to the components of the gel.
Adverse effects:
Allergic reaction to the materials used in manufacturing the device.
Risk class of the medical device:
Class 3 according to GOST 31508, by the order of the Ministry of Health of the Russian Federation dated June 6, 2012, No. 4n, based on the degree of the device’s potential risk in medical use.

TECHNICAL CHARACTERISTICS
The gel shall comply with the requirements of Specification TU 21.20.24‑001‑03852034‑2023, a reference sample, and shall be manufactured in accordance with the manufacturer’s technological documentation approved in the established order, observing sanitary norms and regulations.
Gel composition:
Iron(III) chloride, aminocaproic acid, silicon dioxide, water.
The gel shall not contain foreign inclusions or mechanical impurities.
The gel in its packaging shall be sterile after radiation sterilization according to GOST ISO 11137‑1. Sterilization dose DстDст​ is 25 kGy. Maximum permissible absorbed dose DмаксDмакс​ is 50 kGy.
Individual gel packaging shall be hermetically sealed.
During use, the gel shall be resistant to climatic factors in accordance with GOST 15150 for climatic design category U1.
The gel in transport packaging shall be resistant to climatic effects during transportation and storage under storage conditions class 2 (C) in accordance with GOST 15150.
The gel in transport packaging shall be resistant to mechanical effects during transport under the following conditions:
vibration‑loading frequency 10–55 Hz, displacement amplitude 0.35 mm.
Shelf life: 3 years from the date of sterilization.

PRECAUTIONS
The gel is a sterile medical device intended for single‑use only. It is not subject to repair or technical maintenance.
Repeated sterilization is prohibited.
The product must not be used if the individual packaging is damaged.
Do not use the gel after the expiration date has passed.
The product must not be used if foreign inclusions or mechanical impurities are present.

APPLICATION PROCEDURE
General use method (for all versions):

• Apply the gel onto the bleeding area of the wound until a blood clot forms and bleeding stops.
• If additional clot growth is needed or bleeding persists, apply a new amount of the product over the existing clot without removing it.
• Depending on the size and location of the bleeding area, a gauze pad saturated with the gel may be placed on the wound and used for tamponade.
• After bleeding has stopped, remove the tampon.

For version “GEMOVIS” gel, hemostatic, sterile, single‑use, in Doy‑pack pouches (60 ml, 80 ml, 110 ml):
Preparation before use:

1. Knead the pouch thoroughly over its entire surface.
2. Carefully remove the protective cap, holding the package by the neck area.
3. The product is ready for use.

For version “GEMOVIS” gel, hemostatic, sterile, single‑use, in 10 ml, 35 ml, 65 ml, 85 ml, and 110 ml flacons with applicator:
Preparation before use:

1. Carefully open the package along the perforation line.
2. Remove the corrugated flacon and the applicator nozzle.
3. Knead and shake the flacon vigorously.
4. Remove the protective cap from the flacon.
5. Attach the applicator nozzle to the flacon.
6. The product is ready for use.

For version “GEMOVIS” gel, hemostatic, sterile, single‑use:
a) in thick syringes (20 ml; gel volume 10 ml, 15 ml, 20 ml);
b) in thin syringes (10 ml; gel volume 5 ml, 10 ml).
Preparation before use:

1. Carefully open the package along the perforation line.
2. Remove the syringe from the packaging.
3. Remove the protective cap from the syringe.
4. The product is ready for use.

MAINTENANCE AND REPAIR
Technical servicing and current repair:
The product is a sterile, single‑use medical device and is not subject to repair or technical servicing.
Any attempted repair, reuse after use, or bypassing of the single‑use requirement is not permitted. After use, the device must be disposed of in accordance with regulations for medical waste.

STERILITY INFORMATION AND COMPOSITION ORIGIN
Sterile state of the medical device:
The gel is a sterile, single‑use medical device. Sterilization is carried out by radiation (radiation sterilization) in accordance with GOST ISO 11137‑1‑2011. The sterilizing dose shall be 25 kGy, and the maximum allowable absorbed dose is 50 kGy. Requirements for validation and current control of the sterilization process are defined in GOST ISO 11137‑1‑2011.
Presence of a medicinal product for medical use:
No medicinal product for medical use is employed in the manufacture of the gel. The product is classified and used as a medical device, not as a drug.
Materials of animal and/or human origin:
During the manufacture of the gel, materials of animal and/or human origin are not used. The composition is based solely on synthetic/pharmaceutical‑grade substances (iron(III) chloride, aminocaproic acid, silicon dioxide, and water).

TRANSPORTATION AND STORAGE
Transportation:
The gel in its packaging may be transported by all types of land (covered railroad cars and enclosed truck bodies), water (ship holds), and air (hermetically sealed compartments) transport, in compliance with the rules established for each type of transport, except marine transport as well as unheated and non‑hermetic aircraft compartments, without distance limitations according to GOST 15150.
Transportation of the product in transport packaging by covered transport vehicles shall be carried out under storage conditions class 2 (С) in accordance with GOST 15150.
Storage:
The gel in the manufacturer’s packaging shall be stored in warehouses of the supplier and the consumer (excluding rail‑station storage) under storage conditions class 2 (С) in accordance with GOST 15150.
In transport packaging, the gel shall be stored on shelves, not more than 4 layers high in stacks.

WARRANTY OBLIGATIONS
The manufacturer guarantees that the gel complies with the requirements of the present Technical Specifications (ТУ) provided the user observes the conditions and rules of operation, transportation, and storage specified in the operational documentation.
Warranty claims are not accepted if:

• The gel shows traces of incorrect handling (not in accordance with the instruction provided with the gel), including improper transportation, storage, or use.
• The gel shows mechanical damage or exposure to aggressive liquids, etc.
• Product defects are caused by force‑majeure or natural disasters (fires, water impact, etc.).
• Defects result from foreign objects or substances entering the packaging.
• The gel has been stored in violation of sanitary standards (evidence of activity by animals or insects, etc.).

The warranty service life of the product is 3 years from the date of sterilization. During this period, the product must retain its specified characteristics only if storage, transportation, and handling are carried out in accordance with the declared conditions.

ORDER OF DISPOSAL AND DESTRUCTION OF THE MEDICAL DEVICE
Used gel (after application):
Used gel shall be disposed of as medical waste of Class B in accordance with SanPiN 2.1.3684‑21 “Sanitary‑epidemiological requirements to the maintenance of territories of urban and rural settlements, to water bodies, drinking water and water supply, atmospheric air, soils, residential premises, operation of industrial and public facilities, organization and conduct of sanitary‑epidemiological (preventive) measures.”els24+2
Such waste typically includes items that have been in contact with blood or other biological fluids and may pose an epidemiological risk. Disposal must be carried out via authorized medical‑waste channels (e.g., collection in marked Class B containers with subsequent decontamination and/or destruction according to the SanPiN‑specified procedures).dentalcommunity+1
Unused gel, unfit for use (loss of sterility and/or expiration of shelf life):
Unused gel that is no longer suitable for use—due to compromised sterility or expiration of the shelf life—shall be disposed of as Class A medical waste in accordance with SanPiN 2.1.3684‑21.mos-konteiner+1
Class A refers to non‑epidemiologically hazardous medical waste; such waste is generally handled through standard disposal or recycling routes, still in compliance with SanPiN‑stipulated collection and transport requirements.cgon.rospotrebnadzor+1
In all cases, actual disposal procedures (collection, transport, and final treatment site) must follow the local regulations and the facility’s internal waste‑management policy based on SanPiN 2.1.3684‑21.medpromservis+1

LIST OF APPLIED NATIONAL STANDARDS
There are no national standards that impose requirements on the gel regarding the verification of installation (mounting) of the medical device or confirmation of its readiness for safe operation/use.
This means that, for this specific gel product, conformity assessment and verification of correct installation or readiness for use are not regulated by any dedicated national‑standard methods or procedures; such checks, if performed at all, would be based on the manufacturer’s operational documentation and general requirements for the particular clinical setting rather than on a specific GOST‑style standard.

CONTACT INFORMATION
For questions regarding the quality of the medical device
«GEMOVIS» HEMOSTATIC STERILE GEL SINGLE‑USE FOR LOCAL APPLICATION
according to Technical Specifications TU 21.20.24‑001‑03852034‑2023, manufactured by LLC «VAVI FARM» (OOO «VAVI FARM»), contact:
Company name:
LLC «VAVI FARM» (ООО «ВАВИ ФАРМ»).
Legal address:
197183, St. Petersburg, Sabyrovskaya St., 50, office 403А, Russian Federation.
This entity is registered in St. Petersburg and is the manufacturer of the “GEMOVIS” hemostatic gel brand, with the product listed under registration number RZN 2025/25025 in the Russian medical‑device state register.