3M BAIR HUGGER 360 Gebrauchsanweisung Seite 8

CE Mark
Date of
manufacture
Green Dot
Importer
Keep dry
Manufacturer
Medical
Device
Consult
instructions
for use or
consult
electronic
instructions
for use
Recycle
electronic
equipment
Temperature
limit
Rx Only
Unique device
identifier
Do not re-use
Batch code
Use-by date
Indicates conformity to all applicable
European Union Medical Device Regulations
2797
and Directives.
Indicates the date when the medical device
was manufactured. Source: ISO 15223, 5.1.3
Indicates a financial contribution to national
packaging recovery company per European
Directive No. 94/62 and corresponding national
law. Packaging Recovery Organization Europe.
Indicates the entity importing the
medical device into the locale.
Source: ISO 15223, 5.1.8
Indicates a medical device that
needs to be protected from moisture.
Source: ISO 15223, 5.3.4
Indicates the medical device manufacturer.
Source: ISO 15223, 5.1.1
Indicates the item is a medical device. Source:
MD
ISO 15223, 5.7.7
Indicates the need for the user to consult the
instructions for use. Source: ISO 15223, 5.4.3
DO NOT throw this unit into a municipal
trash bin when this unit has reached the
end of its lifetime. Please recycle. Source:
Directive 2012/19/EC on waste electrical and
electronic equipment (WEEE)
Indicates the temperature limits to which the
60°C
medical device can be safely exposed. Source:
ISO 15223, 5.3.7
-20°C
Indicates that U.S. Federal Law restricts
this device to sale by or on the order of a
Rx Only
healthcare professional. 21 Code of Federal
Regulations (CFR) sec. 801.109(b)(1)
Indicates a carrier that contains Unique Device
UDI
Identifier information. Source: ISO 15223, 5.7.10
Indicates a medical device that is intended for
one single use only. Source: ISO 15223, 5.4.2
Indicates the manufacturer's batch code so
that the batch or lot can be identified. Source:
ISO 15223, 5.1.5
Indicates the date after which the medical device
is not to be used. Source: ISO 15223, 5.1.4
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