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Acumen Iq

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
ACUMEN IQ FDA UDI
Generic Name
Intravenous line sensor, gravity infusion FDA UDI
Device Name
Acumen IQ Fluid Meter FDA UDI
Model / Reference
AIQFM10 FDA UDI
Description
Acumen IQ Fluid Meter FDA UDI

Identifiers

Catalog Number
AIQFM10 FDA UDI
Primary DI / UDI-DI
00690103205824 FDA UDI
FDA Product Code
DQK FDA UDI
QMS FDA UDI
GMDN Term
Intravenous line sensor, gravity infusion FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
870.5600 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Intravenous line sensor, gravity infusion

Acumen Iq by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous line sensor, gravity infusion.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI 2238fb48-294f-4ce9-8b06-433217b6879d 36 fields · synced Jun 8, 2026