AccessGUDID - DEVICE: CRITICATH(TM) SP5327H MONITORING CATHETER (00886333600588)

GUDID

Device Identifier (DI) Information

Brand Name: CRITICATH(TM) SP5327H MONITORING CATHETER
Version or Model: 680058
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 680058
Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Primary DI Number: 00886333600588
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595138793 *Terms of Use

Device Description: Catheter 7FR, 2 Lumen, length 110 cm

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):	Yes
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?
35889	Pulmonary artery balloon catheter, non-electrical	A flexible, non-electrical tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein (e.g., jugular, subclavian), and advanced from the superior vena cava to the pulmonary artery, to measure/monitor a haematological parameter(s) [e.g., pulmonary arterial pressures (e.g., wedge), stroke volume] via the pressure changes at its distal tip. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., external blood pressure transducer) and may include devices dedicated to introduction. This is a single-use 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: 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: Catheter 7FR, 2 Lumen, length 110 cm

Device Record Status

Public Device Record Key: 7f56f0e8-a654-41b8-9d55-fc0ec5265ef2
Public Version Date: December 04, 2023
Public Version Number: 5
DI Record Publish Date: September 22, 2016