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Owlet Dream Sock - Biocompatibility; Symbols Glossary

Owlet Dream Sock
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18. Biocompatibility
The materials that come into contact with the infant/child have undergone extensive biocompatibility testing and comply with ISO
10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-23. Dream Sock is not made with natural latex rubber or DEHP plasticizers. No
additional precautionary measures for infants, children, pregnant or nursing mothers are required for contact with the materials of
Sock 4. Precautions for proper application still apply.
19. Symbols Glossary
Symbol
Meaning
Operating Instructions - Indicates the operating instructions, user manual or instructions for use (IFU).
Manufacturer - Indicates the medical device manufacturer.
Manufacture Date - Indicates the manufacturing date of the labeled component.
Serial Number - Indicates the device serial number of the component.
Model Reference - Indicates the model reference number of the component.
85

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