P.A. Catheter

Basic Information

• Brand Name: P.A. Catheter
• Primary DI: 00886333214709
• Version / Model: 497527
• Catalog Number: 497527
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: d3666ab0-2b34-4e82-9810-e003ab6f0c4c
• Distribution End Date: 2017-11-02

Device Description

P.A. Catheter 6F - 2 Lumen - 110cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	870.1200	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	20886333214703	GS1	Box	5	Not in Commercial Distribution	2017-11-02
Primary	00886333214709	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6F - 110cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry and Away from Sunlight