PEDIASAT XT245SP

GUDID 00690103197488

PEDIASAT OXIMETRY CATHETER SET

Edwards Lifesciences LLC

Oximeter catheter, single-use Oximeter catheter, single-use

• Primary Device ID: 00690103197488
• NIH Device Record Key: 76a8e5af-c7c8-46b3-b0ec-386ce46ea2d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEDIASAT
• Version Model Number: XT245SP
• Catalog Number: XT245SP
• 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 AND DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL AND DRY PLACE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103197488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053609

FDA Product Code

• DXG: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

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