Acumen AFM™ cable - HemoSphere Alta™ monitor HEMAFM100

GUDID 00690103217711

Acumen AFM™ cable - HemoSphere Alta™ monitor

Edwards Lifesciences LLC

General-purpose multi-parameter bedside monitor

• Primary Device ID: 00690103217711
• NIH Device Record Key: e1118913-40f8-492f-b3b3-d0c2c4f6bee4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acumen AFM™ cable - HemoSphere Alta™ monitor
• Version Model Number: HEMAFM100
• Catalog Number: HEMAFM100
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103217711 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242451

FDA Product Code

• DQE: Catheter, Oximeter, Fiber-Optic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-21
• Device Publish Date: 2025-07-11

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• 00690103217711 - Acumen AFM™ cable - HemoSphere Alta™ monitor: 2025-07-21 Acumen AFM™ cable - HemoSphere Alta™ monitor
• 00690103217728 - HemoSphere: 2025-07-21 Pressure cable - HemoSphere Alta ™ monitor
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• 50690103205768 - Acumen IQ Sensor with Fluid Meter: 2025-07-18 ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER 5-PACK
• 50690103205782 - ACUMEN IQ: 2025-07-18 ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP 5-PACK
• 00690103205817 - Acumen IQ Fluid Meter: 2025-07-18 Acumen IQ Fluid Meter
• 50690103205829 - ACUMEN IQ: 2025-07-18 Acumen IQ Fluid Meter