DEVICE: SJM™ (05414734500920)

Download: XML | JSON

Device Identifier (DI) Information

SJM™
3617
3617
ST. JUDE MEDICAL, INC.
05414734500920
GS1
1
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrocardiographic electrode, single-use A non-sterile electrical conductor designed to transmit cardiac bioelectric signals (typically from the thoracic surface) to devices that record and/or process the signals (e.g., electrocardiographs, vectorcardiographs, electrocardiographic monitors). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
NIK Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 158 Degrees Fahrenheit
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
January 19, 2015

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
CLOSE