ForeSight

Basic Information

• Brand Name: ForeSight
• Primary DI: 00690103211320
• Version / Model: FSESS
• Catalog Number: FSESS
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-26
• Public Version: 1
• Public Version Date: 2024-09-03
• Public Version Status: New
• Public Device Record Key: abc756c0-d97b-4c61-8cd1-2739b3f76d43

Device Description

FORESIGHT SMALL SENSOR

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: No
• 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
MUD	Oximeter, Tissue Saturation	Cardiovascular	870.2700	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	50690103211325	GS1	Case	20	In Commercial Distribution
Primary	00690103211320	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K143675	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Small

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH