Unistik

GUDID 00384707900031

Unistik Holder, single use needle holder for blood collection

OWEN MUMFORD USA INCORPORATED

Blood collection set, invasive

• Primary Device ID: 00384707900031
• NIH Device Record Key: 45627c52-a2a8-4b5c-acc5-e7f7cc9a501e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unistik
• Version Model Number: BC 7900
• 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	00384707900000 [Unit of Use]
GS1	00384707900017 [Primary]
GS1	00384707900031 [Package]; Contains: 00384707900017; Package: Case [2400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223854

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-02
• Device Publish Date: 2023-09-22

On-Brand Devices [Unistik]

• 00384707905036: Unistik Luer Adapter, Multi sample luer adapter
• 00384707900031: Unistik Holder, single use needle holder for blood collection