Acumen IQ Cuff AIQCS

GUDID 50690103203320

Acumen IQ Cuff Small

Edwards Lifesciences LLC

Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use
Primary Device ID50690103203320
NIH Device Record Key9f7113bf-2be8-40b5-83e5-8ae35cf3ec1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcumen IQ Cuff
Version Model NumberAIQCS
Catalog NumberAIQCS
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
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
Phone+1(800)822-9637
Emailtech_support@edwards.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103203325 [Primary]
GS150690103203320 [Package]
Contains: 00690103203325
Package: Shipper [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-21
Device Publish Date2021-07-13

On-Brand Devices [Acumen IQ Cuff]

50690103203344Acumen IQ Cuff Large
50690103203337Acumen IQ Cuff Medium
50690103203320Acumen IQ Cuff Small

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