STERILE HEART SURGICAL KIT

WINNER STERILE HEART SURGERY KIT 

ANVISA REGISTRATION: 80201960209

PRODUCT CODE: 1450 

Category:

Description

COMPOSITION:

 WINNER STERILE CARDIAC SURGICAL KIT CAN BE COMPOSED BY CARDIOVASCULAR FIELD, MAYO TABLE FIELD, SIDE FIELD, TABLE INSTRUMENT FIELD, WRAPPED AND REINFORCED SURGICAL APRON BOTH IN POLYPROPYLENE EMBROIDERED, LAMINATED SM, (EM) HYDRORPELLENT PROTECTION BARRIER AND EFFECTIVE BARRIER AGAINST BLOOD AND BODY FLUIDS; "U" FIELD MADE IN VISCOSE NON WOVEN AND PET FILM; POLYETHYLENE COMPOSITE ADHESIVE TAPE AND ACRYLIC ADHESIVE; FLUID COLLECTION BAG MADE OF HIGH DENSITY POLYETHYLENE AND VISCOSE HAND TOWEL. THE COMPOSITION OF THE KIT, REFERRING TO THE ITEMS THAT COMPOSES IT, MAY VARY DEPENDING ON THE CUSTOMER'S NEED.

 

SHELF LIFE:

5 YEARS FROM THE MANUFACTURING DATE. 

 

INDICATION AND PURPOSE OF USE: 

THE WINNER STERILE CARDIAC SURGICAL KIT HAS BEEN DEVELOPED TO MEET HOSPITAL NEEDS RELATING TO CARRYING OUT VARIOUS HEART PROCEDURES. MAY BE USED WHOLE OR IN PARTIES DEPENDING ON THE PROCEDURE THAT WILL BE PERFORMED. 

 

PRECAUTIONS, RESTRICTIONS, WARNINGS, SPECIAL PRECAUTIONS AND CLARIFICATIONS ABOUT THE USE OF THE PRODUCT:

  • SINGLE USE PRODUCT; 
  • PRODUCT FOR EXTERNAL USE;
  • PROHIBITED REPROCESSING PRODUCT;
  • STERILE PRODUCT;
  • OBSERVE THE INSTRUCTIONS FOR USE CAREFULLY;
  • THE PRODUCT IS APIROGENIC AND Nontoxic, DOING NOT GENERALLY OFFER THE USER'S RISK;
  • STORE IN A FRESH AND DRY PLACE, UNDER HEAT AND HUMIDITY;
  • DO NOT USE THE PRODUCT IF ITS ORIGINAL PACKAGING SHOW SIGNS OF VIOLATION OR EXPIRED DATE OF EXPIRATION;
  • THE PRODUCT'S STERELITY IS ONLY GUARANTEED WHILE ITS ORIGINAL PACKAGE REMAINS INTEGRATED AND SEALED;
  • DO NOT USE THE PRODUCT FOR A PURPOSE DIFFERENT FROM THE INDICATED;
  • OPEN THE PACKAGE ONLY AT THE TIME OF USE AND ASEPTICALLY;
  • DISPOSE OF AFTER USE IN AN APPROPRIATE PLACE.

 

ADVERSE EFFECTS:

NO ADVERSE EFFECTS TO THE USE OF THIS PRODUCT ARE REPORTED. 

 

PRODUCT PRESENTATION WAYS:

THE PRODUCT IS PRESENTED IN PRIMARY PACKAGE OF SURGICAL GRADE PAPER CONTAINING 01 KIT PER PACKAGE AND IN SECONDARY PACKAGES CONTAINING UP TO 10 KITS. THE COMPOSITION AND SIZING OF THE KIT ARE VARIED.

 

INSTRUCTIONS FOR USE:

  1. OBSERVE THE INTEGRITY OF THE PACKAGING AND THE INFORMATION CONTAINED ON THE LABELING;
  2. DO NOT USE THE PRODUCT IF THE PACKAGING PRESENTS SIGNS OF VIOLATION / OR EXPIRED DATE / STERELITY EXPIRED;
  3. OPEN THE PACKAGING FROM THE INDICATED LOCATION AND ASEPTICALLY AVOIDING CONTAMINATION OF PARTS OF THE PRODUCT;
  4. REMOVE ITEMS FROM THE KIT TO BE USED ACCORDING TO THE NEED OF THE PROCEDURE;
  5. DISPOSE OF ITEMS TO BE USED IN SUITABLE LOCATIONS FOR USE;
  6. PERFORM THE PROCEDURE;
  7. DISPOSE OF USED AND UNUSED ITEMS IN A PROPER LOCATION;
  8. DO NOT REUSE.

 

MANUFACTURER:

WINNER INDÚSTRIA DE DESCARTÁVEIS LTDA

CNPJ: 05.421.585/0001-37

RUA MACAÚBA, LOTE 01 – ÁGUAS CLARAS

BRASÍLIA – DF CEP: 71928-180

TEL: (61) 3435-6750 / 3435-6754