AccessGUDID - DEVICE: CRITIKIT(TM) SP4572 (00886333600021)

GUDID

Device Identifier (DI) Information

Brand Name: CRITIKIT(TM) SP4572
Version or Model: 680002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 680002
Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Primary DI Number: 00886333600021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595138793 *Terms of Use

Device Description: Injectate delivery system includes a sensor housing with two-way check valve, a cooling coil, a IV administration set, a 10 cc control syringe, 3-way stopcock and two male luer lock protective covers.

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:	Yes
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?
10615	Thermal-dilution cardiac output unit	A unit that measures the blood flow from the heart using the indicator dilution technique, in which a thermal indicator (e.g., cold saline solution or other indicator solution) is injected upstream of the heart and monitored on the downstream side by a balloon-tipped (flow-directed) catheter with a temperature probe. The measured results are reproduced by this device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRB	Probe, Thermodilution

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: Yes
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: Coo;ing Coil with 5.5 coils

Device Record Status

Public Device Record Key: 53db0a43-23c0-4c0f-a2a9-e197a60ca3ef
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016