HemoSphere Alta ALTAALL1

GUDID 00690103217957

HemoSphere Alta advanced monitor (All-on-one)

Edwards Lifesciences LLC

General-purpose multi-parameter bedside monitor
Primary Device ID00690103217957
NIH Device Record Key16ec05c2-b244-4352-9668-76b3bca97f2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemoSphere Alta
Version Model NumberALTAALL1
Catalog NumberALTAALL1
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103217957 [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 Date2025-03-21
Device Publish Date2025-03-13

On-Brand Devices [HemoSphere Alta]

00690103217971HemoSphere Alta monitor (Cardiac)
00690103217964HemoSphere Alta advanced monitor (Smart Recovery)
00690103217957HemoSphere Alta advanced monitor (All-on-one)

Trademark Results [HemoSphere Alta]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEMOSPHERE ALTA
HEMOSPHERE ALTA
97393729 not registered Live/Pending
Edwards Lifesciences Corporation
2022-05-03

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