VAMP Optima VOPTIMA

GUDID 50690103199067

VAMP Optima System

Edwards Lifesciences LLC

Arterial blood sampling kit Arterial blood sampling kit

• Primary Device ID: 50690103199067
• NIH Device Record Key: 1532f53b-9983-4d11-8b19-faddada0cc0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VAMP Optima
• Version Model Number: VOPTIMA
• Catalog Number: VOPTIMA
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

• Length: 84 Inch
• Length: 84 Inch

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	00690103199062 [Primary]
GS1	50690103199067 [Package]; Contains: 00690103199062; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180275

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-30
• Device Publish Date: 2018-10-30

On-Brand Devices [VAMP Optima]

• 50690103199074: VAMP Optima System
• 50690103199067: VAMP Optima System