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

Devices Manufactured by Edwards Lifesciences LLC

57460691952770 - TRUWAVE2026-03-30 PRESSURE MONITORING SET
57460691955887 - TRUWAVE2026-03-30 PRESSURE MONITORING SET
00690103000382 - SWAN-GANZ TRUE SIZE2026-03-24 SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN
50690103218287 - SWAN-GANZ VIP2026-03-24 SWAN-GANZ THERMODILUTION VEINOUS FUSION PORT CATHETER
50690103218607 - SWAN-GANZ TRUE SIZE2026-03-24 TRUE SIZE THERMODILUTION CATHETER
50690103218621 - SWAN-GANZ TRUE SIZE2026-03-24 TRUE SIZE CATHETER DOUBLE LUMEN
50690103218638 - SWAN-GANZ TRUE SIZE2026-03-24 TRUE SIZE MONITORING CATHETER TRIPLE LUMEN
00690103221312 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system2026-02-25 Pulmonic Delivery System - 20 mm (Gen 2) (US)

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.