FLEX-TIP D98500

GUDID 00690103147421

FLEX-TIP TRANSLUMINAL A-PACING PROBE

Edwards Lifesciences LLC

Temporary cardiac pacing balloon catheter

• Primary Device ID: 00690103147421
• NIH Device Record Key: 47b8824f-ed9a-4242-b855-f09845c80985
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEX-TIP
• Version Model Number: D98500
• Catalog Number: D98500
• 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: 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

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	00690103147421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152633

FDA Product Code

• LDF: ELECTRODE, PACEMAKER, TEMPORARY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-03

Devices Manufactured by Edwards Lifesciences LLC

• 50690103000073 - CO-SET INJECTATE ICE BUCKET: 2025-07-24 CO-SET INJECTATE ICE BUCKET 6 PER CASE
• 00690103002546 - CLAMP FOR DPT HOLDER: 2025-07-23 PRESSURE MONITORING ACCESSORY
• 50690103197902 - TRUCLIP: 2025-07-23 TRUCLIP
• 50690103210823 - Combo Kits: 2025-07-23 Pressure Monitoring Set
• 00690103216998 - HEMOSPHERE: 2025-07-23 Mindray OEM Pressure Smart Cable
• 00690103219111 - Cable: 2025-07-23 PHILIPS CARDIAC OUTPUT TEMPERATURE PROBE
• 07460691949867 - PRESSURE MONITORING ACCESSORY: 2025-07-23 PRESSURE MONITORING ACCESSORY
• 57460691956143 - TruWave: 2025-07-23 PRESSURE MONITORING ACCESSORY