Acumen AFM™ cable - HemoSphere Alta™ monitor HEMAFM100

GUDID 00690103217711

Acumen AFM™ cable - HemoSphere Alta™ monitor

Edwards Lifesciences LLC

General-purpose multi-parameter bedside monitor
Primary Device ID00690103217711
NIH Device Record Keye1118913-40f8-492f-b3b3-d0c2c4f6bee4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcumen AFM™ cable - HemoSphere Alta™ monitor
Version Model NumberHEMAFM100
Catalog NumberHEMAFM100
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103217711 [Primary]

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

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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 [Acumen AFM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACUMEN AFM
ACUMEN AFM
88476931 not registered Live/Pending
Edwards Lifesciences Corporation
2019-06-17

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