Изделия для энтерального питания: трубки гастро-еюнальные питательные и наборы:

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Avanos Medical, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Avanos Medical

Дата Авторизация:

2022-05-26

Характеристики продукта

LOW-PROFILE
G-TUBE
Instructions for Use
MIC-KEY
*
SF
GASTROSTOMY FEEDING TUBE
_2_
I
1
2
3
G
A
E
B
C
D
H
F
J
_3_
Rx Only: Federal Law (USA) restricts this device to sale by or on the
order of a physician.
KIT CONTENTS:
1 – MIC-KEY* SF Gastrostomy Feeding Tube (Low-Profile G-Tube)
(FIG. 2)
1 – MIC-KEY* SF Continuous Feed Extension Set, 2 in. (FIG. 1-J)
1 – MIC-KEY* SF Bolus Feed Extension Set, 2 in. (FIG. 1-F)
1 – 6 ml Luer Slip Syringe
1 – Package Water Soluble Lubricant
4 – 4 in. x 4 in. Gauzes
NOT INCLUDED: Stoma Measuring Device (FIG. 3)
DESCRIPTION
The MIC-KEY* SF G-Tube allows for delivery of enteral nutrition and
medication directly into the stomach and/or gastric decompression.
INDICATIONS FOR USE
The MIC-KEY* SF G-Tube is indicated for use in patients who require
long-term feeding, are unable to tolerate oral feeding, who are at low
risk for aspiration, require gastric decompression and/or medication
delivered directly into the stomach through a secured (initial
placement) or formed (replacement) stoma.
CONTRAINDICATIONS
Contraindications for placement of a low-profile gastrostomy feeding
tube include, but are not limited to:
•
Colonic interposition
•
Ascites
•
Portal hypertension
•
Peritonitis
•
Uncorrected coagulopathy
•
Infection around stoma site
•
Uncertainty as to gastrostomy tract direction and length
(abdominal wall thickness)
•
Lack of adherence of the stomach to the abdominal wall
(replacement only)
•
Lack of established gastrostomy tract (replacement only)
•
Evidence of infection around stoma site (replacement only)
•
Presence of multiple stoma fistulous tracts (replacement only)
e
WARNING
DO NOT REUSE, REPROCESS, OR RESTERILIZE THIS MEDICAL DEVICE.
REUSE, REPROCESSING, OR RESTERILIZATION MAY 1) ADVERSELY AFFECT
THE KNOWN BIOCOMPATIBILITY CHARACTERISTICS OF THE DEVICE,
2) COMPROMISE THE STRUCTURAL INTEGRITY OF THE DEVICE, 3) LEAD
TO THE DEVICE NOT PERFORMING AS INTENDED, OR 4) CREATE A RISK
OF CONTAMINATION AND CAUSE THE TRANSMISSION OF INFECTIOUS
DISEASES RESUL