ICU Medical

Basic Information

• Brand Name: ICU Medical
• Primary DI: 00840619060053
• Version / Model: 50327
• Catalog Number: 50327-08
• Company Name: ICU MEDICAL, INC.
• Labeler DUNS: 118380146
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-29
• Public Version: 1
• Public Version Date: 2021-09-06
• Public Version Status: New
• Public Device Record Key: 6a9d953e-156c-4b35-8bc3-5682207d4312

Device Description

TriOx™ SvO2 PA Catheter P7110-EP-H, 7.5F, 110cm, Extra Port, Heparin Coated, LF

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
DQE	Catheter, oximeter, fiber-optic	Cardiovascular	870.1230	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36218	Pulmonary artery balloon catheter, oximetric	A flexible tube with an inflatable balloon at its distal tip designed for measuring pulmonary arterial pressures and mixed venous oxygen saturation (SvO2) levels when connected to an appropriate oximetric patient monitor; it may also measure pulmonary artery wedge pressure. It uses a fibreoptic bundle and light-emitting diodes (LEDs) which using light emitted at two or three different wavelengths (e.g., red or near infrared) from the catheter and reflected back from the red blood cells provide the measurements. It is used in emergencies, for monitoring critically ill patients (e.g., acute respiratory failure, severe head injury) and during surgical procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10840619060050	GS1	CS	6	In Commercial Distribution
Primary	00840619060053	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091268	000