AccessGUDID - DEVICE: IN-LINE INJECTATE SENSOR CABLE-SP4042 (00886333640560)

GUDID

Device Identifier (DI) Information

Brand Name: IN-LINE INJECTATE SENSOR CABLE-SP4042
Version or Model: 684056
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 684056
Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Primary DI Number: 00886333640560
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595138793 *Terms of Use

Device Description: IN-LINE INJECTATE SENSOR CABLE-SP4042 with cable length 98"

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):	Yes
Over the Counter (OTC):	No
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?
62220	Injectate temperature probe	A non-sterile, non-patient contact device intended to be connected to a parent temperature display/monitor (not included) to measure the temperature of a vascular injectate solution (and/or injectate cooling bath) prior to its introduction into the vasculature (e.g., as part of thermodilution-based cardiac output monitoring); it is not intended to contact the injectate directly. It is typically a metal probe with a sensor and connection cable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQO	Catheter, Intravascular, Diagnostic

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
Device Size Text, specify: cable length 98"

Device Record Status

Public Device Record Key: 91b39d22-9fab-491c-ba0f-838315bc470c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 25, 2016