PEDIASAT XT3515SP

GUDID 00690103197532

PEDIASAT OXIMETRY CATHETER SET

Edwards Lifesciences LLC

Oximeter catheter, single-use

• Primary Device ID: 00690103197532
• NIH Device Record Key: 6533ff0a-609b-4e0f-8035-8cf997e7aa64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEDIASAT
• Version Model Number: XT3515SP
• Catalog Number: XT3515SP
• 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 COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DRY PLACE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103197532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053609

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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 [PEDIASAT]

• 00690103197570: PEDIASAT OXIMETRY CATHETER KIT
• 00690103197563: PEDIASAT OXIMETRY CATHETER KIT
• 00690103197556: PEDIASAT OXIMETRY CATHETER KIT
• 00690103197549: PEDIASAT OXIMETRY CATHETER KIT
• 00690103197532: PEDIASAT OXIMETRY CATHETER SET
• 00690103197525: PEDIASAT OXIMETRY CATHETER SET
• 00690103197518: PEDIASAT OXIMETRY CATHETER SET
• 00690103197488: PEDIASAT OXIMETRY CATHETER SET