HEMOSPHERE FORESIGHT MODULE HEMFSM10

GUDID 00690103208573

HEMOSPHERE FORESIGHT MODULE

Edwards Lifesciences LLC

Tissue saturation oximeter
Primary Device ID00690103208573
NIH Device Record Key526b217f-6e33-4415-a890-9bfdd557e86c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEMOSPHERE FORESIGHT MODULE
Version Model NumberHEMFSM10
Catalog NumberHEMFSM10
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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
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

Device Dimensions

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103208573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUDOximeter, Tissue Saturation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-25
Device Publish Date2020-08-17

Devices Manufactured by Edwards Lifesciences LLC

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00690103019339 - HEART VALVE ACCESSOR2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S
00690103166989 - HEART VALVE ACCESSOR2024-10-28 MITRAL SIZER HANDLE
00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 462024-10-28 RING HANDLE - EXTENDED 4"
00690103186437 - FLEXIBLE HANDLE2024-10-28 FLEXIBLE HANDLE
00690103210132 - MITRIS Handle 1140M2024-10-28 11400M valve handle
00690103217773 - Edwards EVOQUE Loading System2024-10-11 Edwards EVOQUE Loading System
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