ForeSight IQ FSESLIQ

GUDID 50690103219611

ForeSight Sensor Large IQ

Edwards Lifesciences LLC

Tissue saturation oximeter sensor, single-use
Primary Device ID50690103219611
NIH Device Record Keyea9323d8-11c9-45d7-929c-7c0531b29bb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameForeSight IQ
Version Model NumberFSESLIQ
Catalog NumberFSESLIQ
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103219616 [Primary]
GS150690103219611 [Package]
Contains: 00690103219616
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQECatheter, Oximeter, Fiber-Optic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-21
Device Publish Date2025-07-11

Devices Manufactured by Edwards Lifesciences LLC

50690103000073 - CO-SET INJECTATE ICE BUCKET2025-07-24 CO-SET INJECTATE ICE BUCKET 6 PER CASE
00690103002546 - CLAMP FOR DPT HOLDER2025-07-23 PRESSURE MONITORING ACCESSORY
50690103197902 - TRUCLIP2025-07-23 TRUCLIP
50690103210823 - Combo Kits2025-07-23 Pressure Monitoring Set
00690103216998 - HEMOSPHERE2025-07-23 Mindray OEM Pressure Smart Cable
00690103219111 - Cable2025-07-23 PHILIPS CARDIAC OUTPUT TEMPERATURE PROBE
07460691949867 - PRESSURE MONITORING ACCESSORY2025-07-23 PRESSURE MONITORING ACCESSORY
57460691956143 - TruWave2025-07-23 PRESSURE MONITORING ACCESSORY

Trademark Results [ForeSight IQ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FORESIGHT IQ
FORESIGHT IQ
98437093 not registered Live/Pending
Edwards Lifesciences Corporation
2024-03-06

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