PRESEP X3820S

GUDID 00690103163384

PRESEP OXIMETRY CATHETER SET 8.5F 20CM

Edwards Lifesciences LLC

Oximeter catheter, single-use

• Primary Device ID: 00690103163384
• NIH Device Record Key: 96973006-a7c8-4b2b-9973-5f23370f4033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESEP
• Version Model Number: X3820S
• Catalog Number: X3820S
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• 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	00690103163384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053609

FDA Product Code

• DQE: CATHETER, OXIMETER, FIBEROPTIC

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

On-Brand Devices [PRESEP]

• 00690103176810: PRESEP OXIMETRY CATHETER 8.5F 16CM W/O THROMBOSHIELD
• 00690103163384: PRESEP OXIMETRY CATHETER SET 8.5F 20CM