Cable 23001B

GUDID 00690103219111

PHILIPS CARDIAC OUTPUT TEMPERATURE PROBE

Edwards Lifesciences LLC

General-purpose patient temperature probe, reusable

• Primary Device ID: 00690103219111
• NIH Device Record Key: 6e7b387a-4ae2-4d52-b572-875c4bb25889
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cable
• Version Model Number: 23001B
• Catalog Number: 23001B
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• 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

Device Dimensions

• Length: 24 Inch
• Length: 24 Inch
• Length: 24 Inch
• Length: 24 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103219111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033444

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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: 2025-07-23
• Device Publish Date: 2025-07-15

On-Brand Devices [Cable]

• 00690103206951: ACUMEN AFM CABLE
• 00690103218428: 896056023 CABLE ASSY,EW MARQUETTE/ROUND
• 00690103218411: 896600022 CABLE ASSY,EW PRUCKA
• 00690103218459: Cable Assy, EW 6 PIN/WK6
• 00690103219111: PHILIPS CARDIAC OUTPUT TEMPERATURE PROBE