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Blom‑Singer
HME/HumidiFilter
®
SYMBOL
EN ISO 15223-
EU 2017/745
EN ISO 15223-
EN ISO 15223-
EN ISO 15223-
EN ISO 15223-
EN ISO 15223-
EN ISO 15223-
EN ISO 15223-
EN ISO 15223-
ISO 7000:2019
ISO 7000:2019
126 I 37602-01H
System Instructions for Use
®
SYMBOLS GLOSSARY (USA only)
SYMBOL
STANDARD
TITLE & REF
No.
Manufacturer;
1:2016
CE Marking;
93/42/EEC
93/42/EEC
Annex XII,
EU 2017/745
Annex V
Authorized
representative
1:2016
European
Community;
Batch code;
1:2016
Batch code;
1:2016
Use-by date;
1:2016
Caution; 5.4.4
1:2016
Do not use
if package
1:2016
is damaged;
Consult
instructions
1:2016
for use; 5.4.3
Do not re-use;
1:2016
Packaging
unit; 2794
Single patient
multiple use;
No.
Indicates the medical device manufacturer, as
defined in EU Directives or Regulations
5.1.1
CE marking of conformity
in the
Indicates the authorized representative in the
European Community
5.1.2
Indicates the manufacturer's catalogue number
so that the medical device can be identified
5.1.6
Indicates the manufacturer's batch code so that
the batch or lot can be identified
5.1.5
Indicates the date after which the medical
device is not to be used
5.1.4
Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions
that cannot, for a variety of reasons, be
presented on the medical device itself
Indicates a medical device that should not be
used if the packaged has been damaged or
opened
5.2.8
Indicates the need for the user to consult the
instructions for use
Indicates a medical device that is intended for
one use, or for use on a single patient during a
5.4.2
single procedure
To indicate the number of pieces in the
package
To indicate that the medical device may be
used multiple times (multiple procedures) on
3706
a single patient
MEANING OF SYMBOL

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