No.
Revision:
Effective:
Page:
EZKZ01
V2.0
2020-03-28
Page 6 of 28
SHANGHAI EARNTZ NONWOVEN.,LTD
Technical File of Earntz Protective Face Mask
Page 6 of 28
1.1.3 Intended use
EARNTZ® Protective Face Mask helps provide respiratory protection against certain
airborne particles. The folded respirator expands for a spacious feel and the pleats help
increase surface area for ease of breathing.
1.1.4 Intended users
Daily users, sports enthusiast, not for medical use.
1.1.5 Basic UDI-DI
The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned
at the level of the device unit of use. It is the main key for records in the UDI
database and is referenced in relevant certificates and EU declarations of
conformity.
UDI-DI: The UDI-DI is a unique numeric or alphanumeric code specific to a model
of device and that is also used as the
‘
access key’ to information stored in a UDI
database.
UDI-PI: The UDI-PI is a numeric or alphanumeric code that identifies the unit of
device production. The different types of UDI-PIs include serial number, lot
number, software identification and manufacturing or expiry date or both types of
date.
A UDI shall be assigned to the device itself or its packaging. The UDI shall contain
two parts: a UDI-DI and a UDI-PI. The UDI-DI shall be unique at each level of
device packaging.
UDI-DI: it is not applicable
1.1.6 The disease status to be diagnosed/targeted/monitored
None
