Appendix D: Symbol Glossary - Lafayette Instrument 01165A User Instructions

Model 01165A/01165APP
Appendix D: Symbol Glossary
The following glossary describes the symbols included on the device label. Some symbols may not
apply to this device.
Manufacturer
Indicates the medical device manufacturer
ISO 15223-1:2016 Ref. 5.1.1
Date of Manufacture
Indicates date when device was
manufactured
ISO 15223-1:2016 Ref. 5.1.3
Batch Code
code
ISO 15223-1:2016 Ref. 5.1.5
Serial Number
number
ISO 15223-1:2016 Ref. 5.1.7
Do not use if package is damaged
Indicates device should not be used if
opened
ISO 15223-1:2016 Ref. 5.2.8
Fragile, handle with care
Indicates device that needs careful
handling
ISO 15223-1:2016 Ref. 5.3.1
Temperature limit
Indicates upper and lower temperature
limits
ISO 15223-1:2016 Ref. 5.3.7
Do not reuse
Indicates a single use device
ISO 15223-1:2016 Ref. 5.4.2
Contains latex
Indicates the presence of natural rubber
latex
ISO 15223-1:2016 Ref. 5.4.5
Humidity Limitation
Indicates the upper and lower limits of
humidity
ISO 15223-1:2016 Ref. 5.3.8
Made in the USA
Device was manufactured in the USA
No Standard Applicable
Fax: (765) 423-4111 . www.lafayetteinstrument.com . info@lafayetteinstrument.com
User Instructions
Authorized Representative
Indicates authorized representative in
the EU
ISO 15223-1:2016 Ref. 5.1.2
Use by Date
Indicates date after which the device is
not to be used
ISO 15223-1:2016 Ref. 5.1.4
Catalog Number
Indicates the manufacturer's part
number
ISO 15223-1:2016 Ref. 5.1.6
Sterile
Indicates that a device has been subject
to sterilization
ISO 15223-1:2016 Ref. 5.2.1
Non-Sterile
Indicates a device has not been subject
to sterilization
ISO 15223-1:2016 Ref. 5.2.7
Keep away from sunlight
Indicates a device needs protection
from sunlight
ISO 15223-1:2016 Ref. 5.3.2
Keep dry
Indicates device should be protected
from moisture
ISO 15223-1:2016 Ref. 5.3.4
Consult Instructions for use
Prompts the user to consult the user
manual
ISO 15223-1:2016 Ref. 5.4.3
Caution
Indicates the need to review cautionary
information
ISO 15223-1:2016 Ref. 5.4.4
CE Mark
Regulation (EC) No. 765/2008 Annex II
Medical Device
medical device
No Standard Applicable
13