Acumen IQ AIQS65

GUDID 50690103200930

ACUMEN IQ SENSOR 60" / 152CM 5-Pack

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 50690103200930
• NIH Device Record Key: d301ca2b-0ed7-418c-8246-a8f7d1a54abb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acumen IQ
• Version Model Number: AIQS65
• Catalog Number: AIQS65
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch
• Length: 60 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103200935 [Primary]
GS1	50690103200930 [Package]; Contains: 00690103200935; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152980

FDA Product Code

• DRS: Transducer, Blood-Pressure, Extravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-04
• Device Publish Date: 2024-08-27

On-Brand Devices [Acumen IQ]

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• 00690103201161: Acumen IQ Sensor
• 00690103201086: Acumen IQ Sensor
• 50690103200947: Acumen IQ Sensor
• 50690103201005: ACUMEN IQ SENSOR 60" / 152CM Double Line Kit -- With VAMP
• 00690103201093: ACUMEN IQ SENSOR 60" / 152CM with Red Cap
• 50690103200954: ACUMEN IQ SENSOR 60" / 152CM with Red Cap
• 50690103200930: ACUMEN IQ SENSOR 60" / 152CM 5-Pack
• 00690103201079: ACUMEN IQ SENSOR 60" / 152CM
• 50690103205829: Acumen IQ Fluid Meter
• 50690103205782: ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP 5-PACK