Unistik VacuFlip

GUDID 00384707001035

Unistik VacFlip, 20G Safety Needle 1"

OWEN MUMFORD USA INCORPORATED

Blood collection set, invasive

• Primary Device ID: 00384707001035
• NIH Device Record Key: b8026d14-28d3-46ea-9da3-661dd38788cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unistik VacuFlip
• Version Model Number: BC 7001
• Company DUNS: 803401454
• Company Name: OWEN MUMFORD USA INCORPORATED
• Device Count: 100
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384707001004 [Unit of Use]
GS1	00384707001011 [Primary]
GS1	00384707001035 [Package]; Contains: 00384707001011; Package: Case [2000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223854

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2023-10-16
• Device Publish Date: 2023-10-06

On-Brand Devices [Unistik VacuFlip]

• 00384707252031: Unistik VacuFlip, 22G safety needle 1.5" with holder
• 00384707251034: Unistik VacuFlip, 22G safety needle 1.5"
• 00384707226032: Unistik VacuFlip, 22G safety needle 1.25" with holder
• 00384707225035: Unistik VacuFlip, 22G safety needle 1.25"
• 00384707202036: Unistik VacuFlip, 22G safety needle 1" with holder
• 00384707201039: Unistik VacuFlip, 22G safety needle 1"
• 00384707152034: Unistik VacuFlip, 21G safety needle 1.5" with holder
• 00384707151037: Unistik VacuFlip, 21G safety needle 1.5"
• 00384707126035: Unistik VacuFlip, 21G safety needle 1.25" with holder
• 00384707125038: Unistik VacuFlip, 21G safety needle 1.25"
• 00384707101032: Unistik VacuFlip, 21G safety needle 1"
• 00384707052037: Unistik VacuFlip, 20G safety needle 1.5" with holder
• 00384707051030: Unistik VacuFlip, 20G safety needle 1.5"
• 00384707026038: Unistik VacuFlip, 20G safety needle 1.25" with holder
• 00384707025031: Unistik VacuFlip, 20G safety needle 1.25"
• 00384707002032: Unistik VacuFlip, 20G safety needle 1" with holder
• 00384707102039: Unistik VacuFlip, 21G safety needle 1" with holder
• 00384707001035: Unistik VacFlip, 20G Safety Needle 1"