HemoSphere HEMCSM10

GUDID 00690103202762

CLEARSIGHT MODULE

Edwards Lifesciences LLC

General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor
Primary Device ID00690103202762
NIH Device Record Key14a97c9b-f059-4bca-adc7-07573b68ac8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemoSphere
Version Model NumberHEMCSM10
Catalog NumberHEMCSM10
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
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103202762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-02
Device Publish Date2021-07-23

On-Brand Devices [HemoSphere]

00690103199321Pressure Cable
00690103197105HemoSphere Roll Stand
00690103197006HemoSphere Advanced Monitor
00690103196993HemoSphere Swan-Ganz Module
00690103196986HemoSphere Oximetry Cable
00690103199338DPT OUT CABLE
00690103202762CLEARSIGHT MODULE

Trademark Results [HemoSphere]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEMOSPHERE
HEMOSPHERE
86899593 5336032 Live/Registered
Edwards Lifesciences Corporation
2016-02-05
HEMOSPHERE
HEMOSPHERE
77402811 3686885 Dead/Cancelled
CRYOLIFE, INC.
2008-02-21
HEMOSPHERE
HEMOSPHERE
74429309 2081831 Dead/Cancelled
Hemosphere, Inc.
1993-08-25

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