Symbol

Standard Reference

Symbol Title

Explanatory Text

labels-manufacturer

ISO 15223-1, Clause 5.1.1

Manufacturer

Indicates the medical device manufacturer.

ISO 15223-1, Clause 5.1.2

Authorized European Representative

Indicates the Authorized representative in the European Community.

ISO 15223-1, Clause 5.1.6

Catalogue or Model Number

Indicates the manufacturer’s catalogue number so that the medical device can be identified.

ISO 15223-1, Clause 5.1.5

Batch Code or Lot Number

Indicates the manufacturer’s batch code so that the batch or lot can be identified.

ISO 15223-1, Clause 5.1.4

Use By

Indicates the date after which the medical device is not to be used.

ISO 15223-1, Clause 5.4.3

Consult Instructions for Use

Indicates the need for the user to consult the instructions for use.

ISO 15223-1, Clause 5.4.4

Attention: Read All Warnings and Precautions in Instructions for Use

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.

US FDA Guidance:Alternative to Certain Prescription Device Labeling Requirements.

Prescription Only

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

ISO 15223-1, Clause 5.3.4

Keep Dry

Indicates a medical device that needs to be protected from moisture.

ISO 15223-1, Clause 5.2.1

Product Subjected to a Sterilization Process

Indicates a medical device that has been subjected to a sterilization process.

ISO 15223-1, Clause 5.2.3

Sterilized by Ethylene Oxide Treatment

Indicates a medical device that has been sterilized using ethylene oxide.

ISO 15223-1, Clause 5.2.9

Sterile Fluid Path

Indicates the presence of a sterile fluid path within the medical device. The method of sterilization is indicated in the empty box. E=Ethylene Oxide, R=Gamma Radiation, A=Aseptic Fill

ISO 15223-1, Clause 5.2.4

Sterilized Using Irradiation

Indicates a medical device that has been sterilized using irradiation.

ISO 15223-1, Clause 5.2.2

Sterilized Using Aseptic Fill

Indicates a medical device that has been sterilized using aseptic fill.

ISO 15223-1, Clause 5.2.8

Do Not Use if Package is Damaged

Indicates a medical device that should not be used if the package has been damaged or opened.

ISO 15223-1, Clause 5.3.2

Keep Away from Sunlight

Indicates a medical device that needs protection from light sources.

ISO 15223-1, Clause 5.4.2

Do Not Reuse

Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

ISO 15223-1, Clause 5.6.3

Non-Pyrogenic

Indicates a medical device that is non-pyrogenic.

ISO 15223-1, Clause 5.6.2

Fluid Path

Indicates the presence of a fluid path.  Used with Non-pyrogenic to indicate the presence of a non-pyrogenic fluid path.

ISO 15223-1, Clause 5.2.6

Do Not Resterilize

Indicates a medical device that is not to be resterilized.

ISO7000

Quantity

Indicates the number of units in the associated packaging.

ISO 15223-1, Clause 5.3.7

Storage Temperature Range

Indicates the temperature limits to which the medical device can be safely exposed.