Acumen IQ Plus

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: Acumen IQ Plus FDA UDI
Generic Name: Blood pressure cuff, single-use FDA UDI
Device Name: Acumen IQ Plus Finger Cuff FDA UDI
Model / Reference: AIQCA2 FDA UDI
Description: Acumen IQ Plus Finger Cuff FDA UDI

Identifiers

Catalog Number: AIQCA2 FDA UDI
Primary DI / UDI-DI: 00690103219531 FDA UDI
510(k) Number: K243781 FDA UDI
FDA Product Code: DQK FDA UDI
DQE FDA UDI
QAQ FDA UDI
MUD FDA UDI
DXN FDA UDI
DSB FDA UDI
FLL FDA UDI
QMS FDA UDI
OLW FDA UDI
GMDN Term: Blood pressure cuff, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1425 FDA UDI
870.1230 FDA UDI
870.2210 FDA UDI
870.2700 FDA UDI
870.1130 FDA UDI
870.2770 FDA UDI
880.2910 FDA UDI
870.5600 FDA UDI
882.1400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Blood pressure cuff, single-use

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

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Cleared under the same submission

K243781 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Edwards Lifesciences LLC

Sources (1)

FDA UDI f50f528d-34ad-4233-84c1-12e8b2aeb0b6 36 fields · synced Jun 8, 2026