Изделия для энтерального питания: комплекты интродукторов для гастростомических питательных трубок:

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

INTRODUCER KIT
FOR FOR JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE
FOR USE WITH: MIC
*
JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE AND
MIC-KEY
*
LOW-PROFILE JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE
Instructions for Use
2
FIG 1
FIG 2
FIG 3
FIG 4
FIG 9
FIG 10
FIG 11
FIG 12
FIG 13
FIG 14
FIG 15
FIG 16
FIG 17
FIG 18
FIG 19
FIG 20A MIC-KEY* J/GJ
FIG 20B MIC* J/GJ
FIG 21A MIC-KEY* J/GJ
FIG 21B MIC* J/GJ
FIG 5
FIG 6
FIG 7
FIG 8
SINGLE USE ONLY
DO NOT USE
IF PACKAGE IS DAMAGED
CAUTION
RX ONLY
DO NOT RESTERILIZE
CONSULT INSTRUCTIONS
FOR USE
STERILIZED USING
ETHYLENE OXIDE
NOT MADE WITH
NATURAL RUBBER LATEX
MR CONDITIONAL
3
AVANOS* INTRODUCER KIT FOR JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE
FOR USE WITH: MIC
* JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE AND MIC-KEY
* LOW-PROFILE JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE
INSTRUCTIONS FOR USE
Rx Only: Federal Law (USA) restricts this device to sale by or on the
order of a physician.
KIT CONTENTS: GASTROINTESTINAL ANCHOR SET WITH
SAF-T-PEXY* T-FASTENERS SCALPEL HEMOSTAT DILATOR INTRODUCER STOMA MEASURING DEVICE SEEKING CATHETER SYRINGE
TABLE A
MIC*/MIC-KEY* TUBE OUTER DIAMETER
RECOMMENDED DILATION
14 Fr
18 FR
16 Fr
20 FR
18 Fr
22 FR
INTENDED USE:
The AVANOS* Introducer Kit for Jejunal and Gastric-Jejunal Feeding
Tube is intended to
facilitate primary placement of the AVANOS* MIC* Jejunal and
Gastric-Jejunal Feeding Tube and
MIC-KEY* Low-Profile Jejunal and Gastric-Jejunal Feeding Tube.
CONTRAINDICATIONS:
Contraindications include, but are not limited to ascites, colonic
interposition, portal
hypertension, gastric varices, peritonitis, aspiration pneumonia and
morbid obesity (stoma
lengths longer than 10 cm). WARNING: VERIFY PACKAGE INTEGRITY PRIOR TO OPENING. DO NOT USE IF
PACKAGE IS DAMAGED
OR STERILE BARRIER COMPROMISED. 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