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XSymbol | Symbol Title | Reference number | Description | Standard Title and Designation number |
---|---|---|---|---|
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Manufacturer | 5.1.1 (ISO 7000 No 3082) |
Indicates the medical device manufacturer, as defined in EU directives 90/385/EEC, 93/42/EEC and 98/79/EEC | ISO &ANSI/AAMI ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements |
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Catalogue number | 5.1.6 (ISO 7000 No 2493) |
The manufacturerís catalogue number so that the medical device can be identified | ISO &ANSI/AAMI ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements |
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Batch code | 5.1.5 (ISO 7000 2492) |
Indicates the manufacturerís batch code so that the batch or lot can be identified | ISO &ANSI/AAMI ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements |
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Use-by date | 5.1.4 (ISO 7000 2607) |
Indicates the date after which the medical device is not to be used | ISO &ANSI/AAMI ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements |
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Do not re-use | 5.4.2 (ISO 7000 1051) |
Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure | ISO &ANSI/AAMI ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements |
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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 &ANSI/AAMI ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements |
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Keep dry | 5.3.4 (ISO 7000 0626) |
Indicates a medical device that needs to be protected from moisture | ISO &ANSI/AAMI ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements |
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Keep away from sunlight | 5.3.2 (ISO 7000 0624) |
Indicates a medical device that needs protection from light sources | ISO &ANSI/AAMI ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements |
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Consult instructions for use | 5.4.3 (ISO 7000 1641) |
Indicate the need for the user to consult the instructions for use | ISO &ANSI/AAMI ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements |
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Sterilized using ethylene oxide | 5.2.3 (ISO 7000 2501) |
Indicated a medical device that has been sterilized using ethylene oxide | ISO &ANSI/AAMI ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1: General requirements |
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Contains or presence of phthalates (DEHP) | 4.2 (ISO 7000 2725) |
Medical device contain Phtalates (DEHP) | EN 15986:2011 |
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Prescription use | N/A | Caution: Federal law restricts this device to sale by or order of a physician | 21 CFR 801.109 |
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