CRITICATH(TM) SP5105H TD CATHETER

Basic Information

• Brand Name: CRITICATH(TM) SP5105H TD CATHETER
• Primary DI: 00886333600441
• Version / Model: 680044
• Catalog Number: 680044
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Labeler DUNS: 595138793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: 2a5f122e-9f24-4285-a9c3-bc808546d70a

Device Description

Heparin coated catheter 5FR,4Lumen, length 80 cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRB	Probe, Thermodilution	Cardiovascular	870.1915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34925	Pulmonary artery balloon catheter, electrical	A flexible tube with an inflatable balloon(s) and electrical component(s) [e.g., thermistor, fibreoptic bundle] at its distal tip designed to be introduced percutaneously into the venous system via a central vein, and advanced to the pulmonary artery, to measure/monitor haematological parameters [e.g., pulmonary arterial pressures (e.g., wedge), cardiac output, cardiac index, mixed venous oxygen saturation (SvO2)]; it might use thermal dilution techniques and in addition be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50886333600446	GS1	Tyvek Tray	20	In Commercial Distribution
Primary	00886333600441	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			catheter 5FR,4Lumen, length 80 cm