ForeSight IQ

Basic Information

• Brand Name: ForeSight IQ
• Primary DI: 00690103219616
• Version / Model: FSESLIQ
• Catalog Number: FSESLIQ
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-11
• Public Version: 1
• Public Version Date: 2025-07-21
• Public Version Status: New
• Public Device Record Key: ea9323d8-11c9-45d7-929c-7c0531b29bb8

Device Description

ForeSight Sensor Large IQ

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: MR Unsafe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	870.1230	2
DSB	Plethysmograph, Impedance	Cardiovascular	870.2770	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2
FLL	Continuous Measurement Thermometer	General Hospital	880.2910	2
MUD	Oximeter, Tissue Saturation	Cardiovascular	870.2700	2
QAQ	Adjunctive Predictive Cardiovascular Indicator	Cardiovascular	870.2210	2
QEM	Cerebral Oximeter	Cardiovascular	870.2700	2
QMS	Adjunctive Open Loop Fluid Therapy Recommender	Cardiovascular	870.5600	2
QNL	Medium-Term Adjunctive Predictive Cardiovascular Indicator	Cardiovascular	870.2210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46618	Tissue saturation oximeter sensor, single-use	A photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. It is connected to a tissue saturation oximeter via a fibreoptic cable and will typically include a light shield to protect the measurements from ambient light. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50690103219611	GS1	Case	20	In Commercial Distribution
Primary	00690103219616	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K242451	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool and dry place