natus EMG - Glossary of Symbols

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Page 5 of 6

Glossary of Symbols:

Symbol

Standard

Reference

Standard Title Symbol Title Explanation

Not

applicable

Not applicable

An indication of

Medical Device

This product is a medical device.

21 CFR Part

801.109(b)(1)

Labeling-Prescription

devices

Prescription only

Indicates that the product is

authorized for sale by or on the

order of a licensed healthcare

practitioner.

ISO 15223-1

Symbol 5.4.5

(Reference

Annex B for

the general

prohibition

symbol)

Medical devices —

Symbols to be used

with medical device

labels, labelling and

information to be

supplied

Not made with natural

rubber latex

Indicates that the medical device

is not made with natural rubber

latex.

2012/19/EU

Waste Electrical and

Electronic Equipment

(WEEE)

Disposal at end of

operating life

instructions

Indicates that electrical and

electronic equipment waste

should not be discarded together

with unseparated waste but must

be collected separately.

ISO 15223-1

Symbol 5.1.1

Medical devices —

Symbols to be used

with medical device

labels, labelling and

information to be

supplied

Manufacturer

Indicates the medical device

manufacturer.

ISO 15223-1

Symbol 5.1.2

Medical devices —

Symbols to be used

with medical device

labels, labelling and

information to be

supplied

Authorized

representative in the

European Community

Indicates the Authorized

representative in the European

Community.

ISO 15223-1

Symbol 5.1.3

Medical devices —

Symbols to be used

with medical device

labels, labelling and

information to be

supplied

Date of manufacture

Indicates the date when the

medical device was

manufactured.

ISO 15223-1

Symbol 5.1.5

Medical devices —

Symbols to be used

with medical device

labels, labelling and

information to be

supplied

Batch code

Indicates the manufacturer's

batch code so that the batch or

lot can be identified.

ISO 15223-1

Symbol 5.1.6

Medical devices —

Symbols to be used

with medical device

labels, labelling and

information to be

supplied

Catalogue number

Indicates the manufacturer’s

catalogue number so that the

medical device can be identified.

ISO 15223-1

Symbol 5.4.3

Annex A

#A.15

Medical devices —

Symbols to be used

with medical device

labels, labelling and

information to be

supplied

Consult instructions

for use

Indicates an instruction to consult

an electronic instructions for use

(eIFU).