PIVO™ Pro Needle-free Blood Collection Device 393657

GUDID 50382903936576

PIVO™ Pro Needle-free Blood Collection Device 20 GA Compatible

BECTON, DICKINSON AND COMPANY

Blood collection tube holder, single-use

• Primary Device ID: 50382903936576
• NIH Device Record Key: b9db1d0a-074f-401a-8056-7d04f061decc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIVO™ Pro Needle-free Blood Collection Device
• Version Model Number: 393657
• Catalog Number: 393657
• Company DUNS: 124987988
• Company Name: BECTON, DICKINSON AND COMPANY
• 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: 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903936571 [Primary]
GS1	30382903936572 [Package]; Contains: 00382903936571; Package: Shelfpack [50 Units]; In Commercial Distribution
GS1	50382903936576 [Package]; Contains: 30382903936572; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230865

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-07
• Device Publish Date: 2023-11-29

On-Brand Devices [PIVO™ Pro Needle-free Blood Collection Device]

• 50382903936576: PIVO™ Pro Needle-free Blood Collection Device 20 GA Compatible
• 50382903936538: PIVO™ Pro Needle-free Blood Collection Device 22 GA Compatible