VOLUMEVIEW VLV8R5

GUDID 07460691950481

VOLUMEVIEW SENSOR,84",5P,RED C

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 07460691950481
• NIH Device Record Key: a39bf0e5-d528-404d-a14b-dc08a1fc7655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOLUMEVIEW
• Version Model Number: VLV8R5
• Catalog Number: VLV8R5
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07460691950481 [Primary]
GS1	57460691950486 [Package]; Package: Shipper [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100739

FDA Product Code

• KRB: PROBE, THERMODILUTION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-03

On-Brand Devices [VOLUMEVIEW]

• 00690103190427: CV THERMISTOR KIT 5 PACK
• 00690103187076: VOLUMEVIEW SET,4F,16CM,60",5P
• 00690103187069: VOLUMEVIEW SET,4F,16CM,84",5P
• 00690103187052: VOLUMEVIEW SET,4F,16CM,84",1P
• 00690103187045: VOLUMEVIEW SET,4F,16CM,60",1P
• 00690103187038: VOLUMEVIEW SET,5F,20CM,60",5P
• 00690103187021: VOLUMEVIEW COMBO KIT
• 00690103187014: VOLUMEVIEW SET,5F,20CM,84",1P
• 00690103187007: VOLUMEVIEW SET,5F,20CM,60",1P
• 00690103185485: FEMORAL CATHETER KIT (4F, 16CM)
• 00690103183924: FEMORAL CATHETER KIT
• 00690103183917: 1-FEMORAL CATHETER KIT (5F, 20 CM), SINGLE PACK
• 00690103183900: CV THERMISTOR KIT 5 PACK
• 07460691950481: VOLUMEVIEW SENSOR,84",5P,RED C