|
Device
|
Device
|
|
identifier
|
.id
|
udi
udiCarrier
|
.id
and
.code
|
|
deviceIdentifier
|
Role.id.extension
|
name
issuer
|
.displayName
Role.id.root
|
|
jurisdiction
|
Role.scoper
|
carrierHRF
carrierAIDC
|
Role.id.extension
|
carrierAIDC
carrierHRF
|
Role.id.extension
|
issuer
entryType
|
Role.id.root
NA
|
entryType
status
|
NA
.statusCode
|
status
distinctIdentificationCode
|
.statusCode
.lotNumberText
|
type
manufacturer
|
.code
.playedRole[typeCode=MANU].scoper.name
|
lotNumber
manufactureDate
|
.lotNumberText
.existenceTime.low
|
manufacturer
expirationDate
|
.playedRole[typeCode=MANU].scoper.name
.expirationTime
|
manufactureDate
lotNumber
|
.existenceTime.low
.lotNumberText
|
expirationDate
serialNumber
|
.expirationTime
.playedRole[typeCode=MANU].id
|
model
type
|
.playedRole[typeCode=MANU].code
|
version
modelNumber
|
.softwareName
(included
as
part)
|
|
partNumber
| .playedRole[typeCode=MANU].id |
|
patient
|
.playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]
|
|
owner
|
.playedRole[typeCode=OWN].scoper
|
|
contact
|
.scopedRole[typeCode=CON].player
|
|
location
|
.playedRole[typeCode=LOCE].scoper
|
|
url
|
.telecom
|
|
note
|
.text
|
|
safety
|
NA
|
UDI
is
a
unique
numeric
or
alphanumeric
code
that
consists
of
two
parts:
(1)
a
device
identifier
(DI),
a
mandatory,
fixed
portion
of
a
UDI
that
identifies
the
labeler
and
the
specific
version
or
model
of
a
device,
and
(2)
a
production
identifier
(PI),
a
conditional,
variable
portion
of
a
UDI
that
identifies
one
or
more
of
the
following
when
included
on
the
label
of
a
device:
(2a)
the
lot
or
batch
number
within
which
a
device
was
manufactured;
(2b)
the
serial
number
of
a
specific
device;
(2c)
the
expiration
date
of
a
specific
device;
(2d)
the
date
a
specific
device
was
manufactured;
(2e)
the
distinct
identification
code
required
by
§1271.290(c)
for
a
human
cell,
tissue,
or
cellular
and
tissue-based
product
(HCT/P)
regulated
as
a
device.
|
Device
|
|
|
identifier
|
The
serial
number
which
is
a
component
of
the
production
identifier
(PI),
a
conditional,
variable
portion
of
a
UDI.
The
identifier.type
code
should
be
set
to
“SNO”(Serial
Number)
and
the
system
left
empty.
|
udi
definition
| |
|
udiCarrier
|
|
|
deviceIdentifier
|
The
device
identifier
(DI),
a
mandatory,
fixed
portion
of
a
UDI
that
identifies
the
labeler
and
the
specific
version
or
model
of
a
device.
|
name
issuer
|
Propietary/Trade
Name
of
the
medical
Device
as
used
in
the
labeling
or
catalog
All
UDIs
are
to
be
issued
under
a
system
operated
by
an
Jurisdiction-accredited
issuing
agency.
GS1
DIs:
http://hl7.org/fhir/NamingSystem/gs1
HIBCC
DIs:
http://hl7.org/fhir/NamingSystem/hibcc
ICCBBA
DIs
for
blood
containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood
ICCBA
DIs
for
other
devices:
http://hl7.org/fhir/NamingSystem/iccbba-other
|
|
jurisdiction
|
|
carrierHRF
A
unique
device
identifier
(UDI)
on
a
device
label
in
plain
text
carrierAIDC
|
A
unique
device
identifier
(UDI)
on
a
device
label
a
form
that
uses
automatic
identification
and
data
capture
(AIDC)
technology.
|
issuer
carrierHRF
|
All
UDIs
are
to
be
issued
under
A
unique
device
identifier
(UDI)
on
a
system
operated
by
an
Jurisdiction-accredited
issuing
agency.
GS1
DIs:
http://hl7.org/fhir/NamingSystem/gs1
HIBCC
DIs:
http://hl7.org/fhir/NamingSystem/hibcc
ICCBBA
DIs
for
blood
containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood
ICCBA
DIs
for
other
devices:
http://hl7.org/fhir/NamingSystem/iccbba-other
device
label
in
plain
text
|
|
entryType
|
|
|
status
|
|
type
statusReason
|
Type
description
using
GMDN
or
other
code
system
|
lotNumber
distinctIdentificationCode
|
The
lot
or
batch
number
within
which
a
device
was
manufactured
-
which
is
a
component
of
the
production
identifier
(PI),
a
conditional,
variable
portion
of
a
UDI.
|
|
manufacturer
|
N/A
|
|
manufactureDate
|
The
date
a
specific
device
was
manufactured
-
which
is
a
component
of
the
production
identifier
(PI),
a
conditional,
variable
portion
of
a
UDI.
For
FHIR,
The
datetime
syntax
must
converted
to
YYYY-MM-DD[THH:MM:SS].
If
hour
is
present,
the
minutes
and
seconds
should
both
be
set
to
“00”.
|
|
expirationDate
|
the
expiration
date
of
a
specific
device
-
which
is
a
component
of
the
production
identifier
(PI),
a
conditional,
variable
portion
of
a
UDI.
For
FHIR,
The
datetime
syntax
must
converted
to
YYYY-MM-DD[THH:MM:SS].
If
hour
is
present,
the
minutes
and
seconds
should
both
be
set
to
“00”.
|
model
lotNumber
|
The
lot
or
batch
number
within
which
a
device
was
manufactured
-
which
is
a
component
of
the
production
identifier
(PI),
a
conditional,
variable
portion
of
a
UDI.
|
|
serialNumber
| |
|
deviceName
| |
|
name
| |
|
type
| |
|
modelNumber
| |
|
partNumber
| |
|
type
| |
|
specialization
| |
|
systemType
| |
|
version
|
|
|
version
|
|
|
type
| |
|
component
| |
|
value
| |
|
property
| |
|
type
| |
|
valueQuanity
| |
|
valueCode
| |
|
patient
|
|
|
owner
|
|
|
contact
|
|
|
location
|
|
|
url
|
|
|
note
|
|
|
safety
|
|
|
parent
| |
Administration
.
Page
versions:
R5
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R4
R3
R2
|
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change