Acumen IQ Sensor with Vamp with TruWave AIQSFM6C502

GUDID 50690103205836

ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP WITH TRUWAVE 5-PACK

Edwards Lifesciences LLC

Intravenous line sensor, gravity infusion
Primary Device ID50690103205836
NIH Device Record Key134f6edf-ee28-4d42-ba50-841a4cb0c94b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcumen IQ Sensor with Vamp with TruWave
Version Model NumberAIQSFM6C502
Catalog NumberAIQSFM6C502
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, day place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103205831 [Primary]
GS150690103205836 [Package]
Contains: 00690103205831
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-18
Device Publish Date2025-07-10

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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

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