FDA.reportPublic FDA data

Acumen IQ Sensor with Fluid Meter

Primary DI
00690103205763
Brand
Acumen IQ Sensor with Fluid Meter
Company
Edwards Lifesciences LLC
Model
AIQSFM65
Catalog number
AIQSFM65
Device description
ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER 5-PACK
Published
2025-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable
QMSAdjunctive Open Loop Fluid Therapy Recommender

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
QMSAdjunctive Open Loop Fluid Therapy RecommenderCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50690103205768PackageGS15In Commercial Distribution
00690103205763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010320576850690103205768
00690103205763006901032057636901032057630690103205763

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line sensor, gravity infusionA noninvasive electronic device intended to be fitted within a gravity-fed intravenous (IV) line to detect flow rate of fluids being administered to a patient. It has a Luer connection at each end and in intended for electrical connection to receive power from, and send data to, a hemodynamic patient monitor. Flow rate is determined by microthermal measurement principle technology. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103219500Edwards Reusable Rail10500RL10500RL2025-07-09
00690103205084FOGARTY120403FP120403FP2020-09-15
00690103218602SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
00690103218626SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
00690103218633SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103000245SWAN-GANZ TRUE SIZE096F6096F6P2016-09-03
00690103000269SWAN-GANZ110F5110F52016-09-03
00690103000276SWAN-GANZ TRUE SIZE111F7111F7P2016-09-03
00690103000313SWAN-GANZ TRUE SIZE114F7114F7P2016-09-03
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06

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Primary DI, Brand, Company table
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00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
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