PIVO 22G

GUDID 00850984007034

PIVO (2.0) 22G Compatible device

VELANO VASCULAR, INC.

Blood collection tube holder, single-use

• Primary Device ID: 00850984007034
• NIH Device Record Key: 10e3e75d-21db-4334-8fac-0a0b4958548a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIVO 22G
• Version Model Number: 202-0006
• Company DUNS: 079714011
• Company Name: VELANO VASCULAR, INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844 835 2668
• Email: info@velanovascular.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850984007034 [Primary]
GS1	10850984007031 [Package]; Package: Sales Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163508

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-07-11

On-Brand Devices [PIVO 22G]

• 00850984007034: PIVO (2.0) 22G Compatible device
• 10850984007017: PIVO 22G Compatible device