AccessGUDID - DEVICE: Trulink (10841522122583)

GUDID

Device Identifier (DI) Information

Brand Name: Trulink
Version or Model: Adapter Cables
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 700-0028-00
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522122583
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: CABLE ASSY,ADAPTOR,P1-2/P3-4,91496

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):	Yes
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?
36553	Patient monitoring system module, multifunction	A small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 122 cm/4 ft Length

Device Record Status

Public Device Record Key: f389702f-0aaf-4682-bb04-49e4eab93320
Public Version Date: October 23, 2023
Public Version Number: 7
DI Record Publish Date: May 31, 2017