ACUMEN IQ SENSOR FOR AFM AIQSAFM8R5

GUDID 50690103201067

ACUMEN IQ 84" / 213CM FOR USE WITH ASSISTED FLUID MANAGEMENT SOFTWARE FEATURE RED CAP FIVE PACK

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 50690103201067
• NIH Device Record Key: d7bfca10-57ab-4d6c-92f9-58385c6e2bb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACUMEN IQ SENSOR FOR AFM
• Version Model Number: AIQSAFM8R5
• Catalog Number: AIQSAFM8R5
• 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: false
• 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

Device Dimensions

• Length: 84 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103201062 [Primary]
GS1	50690103201067 [Package]; Contains: 00690103201062; Package: Shipper [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: 2019-07-17
• Device Publish Date: 2019-07-09

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