CHAPTER TWO
Equipment identication
28
Equipment identication
2.8.2 Serial number
The Otoport DP+TE OAE+ ABR system complies with the unique device
identier system to aid the identication of medical devices within the
healthcare supply chain.
The elds in the serial number are made up of the following parts:
(01) Company prex: Otodynamics, Item reference: Otoport DP+TE OAE+ABR
(11) Production date: 31st January 2015
(21) Serial numbers: 1234 (Otoport) - 1234 (ABR) (if ABR module is supplied)
(240) Additional product ID: BRT (used to identify any hardware modules tted)
(250) Secondary serial number: AB1 (This is a proprietary electronic device
identier, called GSN).
This information is also contained in the adjacent barcode.
2.8.3 Certication or regulatory marks
The label features one or more of the following certication/regulatory
marks:
CE Mark (with Notied Body number) (EEA)
WEEE Directive applies (EEA)
0120