AccessGUDID - DEVICE: Trulink (10841522101878)

GUDID

Device Identifier (DI) Information

Brand Name: Trulink
Version or Model: 90481
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 012-0496-00
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522101878
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: CABLE,EEG,SHIELDED,12-LEAD,BLUE,305CM/10 FT

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSI	DETECTOR AND ALARM, ARRHYTHMIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103142	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
Storage Environment Temperature: exactly 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0aad7473-e282-4732-b26c-3dbc678df3f1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 20, 2016