Philips EarlyVue VS30 User Manual

EarlyVue VS30 Instructions for Use xiii
Regulatory and Safety Specifications
Unique Device Identification
Product labels include Unique Device Identification (UDI) as required by U.S. regulation.
The UDI label contains a device identifier (DI) and a production identifier (PI). The
identifiers are machine and human readable.
• The Device Identifier (DI) is a unique GSI GTIN-12 number that has been registered
with the US FDA.
• The Production Identifier (PI) is a combination of Lot or Batch Number, Manufacturing
Dates, Serial Number and/or Expiration Date, as applicable for the device.
In the following sample label, the UDI information is outlined in red. The XXXX strings
represent the human readable DI and PI.
Manufacturer
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard Strasse 2
71034 Böblingen
Germany
Australia and New Zealand Sponsor
Philips Electronics Australia Ltd.
65 Epping Road,
North Ryde
NSW 2113
Australia
Rx Only
Caution
United States Federal Law restricts this device to sale by or on the order of a physician.

Philips EarlyVue VS30 Specifications

General

Brand	Philips
Model	EarlyVue VS30
Category	Medical Equipment
Language	English