20MM X 4CM X 130CM EDWARDS BALLOON CATHETER 9350BC20A

GUDID 00690103191813

EDWARDS BALLOON CATHETER

Edwards Lifesciences LLC

Cardiac valvuloplasty catheter

• Primary Device ID: 00690103191813
• NIH Device Record Key: 056b20d2-1f54-42db-bd10-b332049f34b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 20MM X 4CM X 130CM EDWARDS BALLOON CATHETER
• Version Model Number: 9350BC20
• Catalog Number: 9350BC20A
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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	00690103191813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140241

FDA Product Code

• OZT: Balloon aortic valvuloplasty

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: 2015-12-01

Devices Manufactured by Edwards Lifesciences LLC

• 00690103218527 - Vascular: 2024-08-16 CABLE ASSY,10PIN/SIEMENS,MDR
• 00690103218534 - PX1800: 2024-08-16 CABLE ASSY,EW TRUWAVE,ROHS,MDR
• 00690103218541 - PX1800: 2024-08-16 CABLE ASSY, 6 PIN/MS3106, MDR
• 00690103218558 - PX1800: 2024-08-16 CBL ASSY,12 PIN/KONTRON,ROHS
• 00690103218565 - PX1800: 2024-08-16 CABLE ASSY, EW SIEMENS, MDR
• 00690103218572 - PX1800: 2024-08-16 CABLE ASSEMBLY,EW, ROHS
• 00690103219265 - FLOTRAC: 2024-08-14 FLOTRAC SENSOR JR
• 00690103219357 - FLOTRAC: 2024-08-14 FLOTRAC SENSOR JR