Flex Vessel Prep FSC 4-120 Mode D'emploi page 2

Symbol Description of the Symbol
Manufacturer's catalog number, so that the medical device can be identified
Indicates the manufacturer's batch code so that the batch or lot can be
identified.
Indicates a medical device that is intended for one single use only
Indicates a medical device that is not to be resterilized.
Indicates a medical device that has been sterilized using ethylene oxide.
Indicates the date after which the medical device is not to be used.
Indicates the need for the user to consult the instructions for use.
Indicates a medical device that needs protection from light sources.
Indicates a medical device that needs to be protected from moisture.
Indicates a medical device that should not be used if the package has been
damaged or opened.
U.S. and Foreign Patents pending
Prescription use only
Indicates the medical device manufacturer
VentureMed Group, Inc.
2800 Campus Drive
Suite 50
Plymouth, Minnesota 55441
US
TEL: (763)-951-0280
www.venturemedgroup.com
Authorized Representative in the European Union
MedNet EC-REP GmbH
Borkstraße 10
48163 Münster, Germany
CE Marked per the Medical Device Directive 93/42/EEC of the European Union.
The Notified Body is BSI (ID#2797)
Indicates a single sterile barrier system with protective packaging outside
Indicates that caution is necessary when operating the device or control close to
where the symbol is placed, or that the current situation needs operator
awareness or operator action in order to avoid undesirable consequences
Indicates the item is a medical device
Indicates a carrier that contains unique device identifier information
100073 Revision R
Glossary of symbols used on labeling
Date of Issue: 2022-06
Standard Title of symbol and reference number
ISO 15223-1:2021 Catalog number (5.1.6)
Batch code (5.1.5)
ISO 15223-1:2021
Do not reuse (5.4.2)
ISO 15223-1:2021
ISO 15223-1:2021 Do not resterilize (5.4.2)
ISO 15223-1:2021 Sterilized using ethylene oxide (5.2.2)
Use-by date (5.1.4)
ISO 15223-1:2021
ISO 15223-1:2021 Consult instructions for use (5.4.3)
ISO 15223-1:2021 Keep away from sunlight (5.3.2)
ISO 15223-1:2021 Keep dry (5.3.4)
ISO 15223-1:2021 Do not use if package is damaged (5.2.8)
Not Applicable Not Applicable
21 CFR 801 Title 21
FDA Medical
801.109(b)(1)
Devices Part 801
Labeling
ISO 15223-1:2021 Manufacturer (5.1.1)
Indicates the Authorized representative
ISO 15223-1:2021
in the European Community (5.1.2)
MDD 93/42/EEC Compliance with MDD 93/42/EEC
Single sterile barrier system with protec-
ISO 15223-1:2021
tive packaging outside (5.2.14)
ISO 15223-1:2021 Caution (5.4.4)
ISO 15223-1:2021 Medical device (5.7.7)
Unique device identifier
ISO 15223-1:2021
(5.7.10)
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