AccessGUDID - DEVICE: CABLE CHECKER TCA-003 (00886333640034)

GUDID

Device Identifier (DI) Information

Brand Name: CABLE CHECKER TCA-003
Version or Model: 684003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 684003
Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Primary DI Number: 00886333640034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595138793 *Terms of Use

Device Description: A reusable device to verify the condition of an interface cable.

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
60331	Pneumatic line tester, battery-powered	A portable, battery-powered, general-purpose device intended to measure pneumatic line flow rates and pressures (positive and negative) in order to calibrate or test a medical (e.g., anaesthesia machines, suction devices) or industrial device and is not dedicated to a specific discipline. It typically consists of a hand-held electronic box with appropriate pneumatic line connections, a digital display and might also contain built-in sensors (e.g., thermometer, hygrometer) in order to measure additional properties (e.g., atmospheric pressure, humidity and temperature). It is intended to be used by a professional in a professional setting (e.g., clinical engineering).	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 [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: 943157d8-8c26-4f81-902f-883548a79110
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 17, 2016