ACUMEN IQ SENSOR AIQS8S102

GUDID 00690103201130

ACUMEN IQ SENSOR 84" / 213CM Double Line Kit -- With VAMP

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use
Primary Device ID00690103201130
NIH Device Record Key6e4ae7c5-9dd4-4e03-8f78-f08516b2f4c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameACUMEN IQ SENSOR
Version Model NumberAIQS8S102
Catalog NumberAIQS8S102
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

Length84 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103201130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRSTransducer, Blood-Pressure, Extravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-17
Device Publish Date2019-07-09

On-Brand Devices [ACUMEN IQ SENSOR]

00690103201130ACUMEN IQ SENSOR 84" / 213CM Double Line Kit -- With VAMP
50690103201012ACUMEN IQ SENSOR 84" / 213CM Double Line Kit - No VAMP
50690103200985ACUMEN IQ SENSOR W/ VAMP ADULT 60"/152cm 5-Pack
00690103201109ACUMEN IQ SENSOR WITH VAMP SYSTEM 60" / 152CM
50690103200978ACUMEN IQ SENSOR 84" / 213CM WITH EXTRA STOPCOCK

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