Unistik ShieldLock

GUDID 00384707122037

Unistik ShieldLock 21G Safety Winged Set w/ Luer and holder 12" tubing

OWEN MUMFORD USA INCORPORATED

Blood collection set, invasive

• Primary Device ID: 00384707122037
• NIH Device Record Key: 90fe0fa0-2002-4ddf-be39-b138064e6506
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unistik ShieldLock
• Version Model Number: WS 7122
• Company DUNS: 803401454
• Company Name: OWEN MUMFORD USA INCORPORATED
• Device Count: 50
• 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	00384707122006 [Unit of Use]
GS1	00384707122013 [Primary]
GS1	00384707122037 [Package]; Contains: 00384707122013; Package: Case [1000 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: 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

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• 00384707522035: Unistik ShieldLock 25G Safety Winged Set w/ Luer and Holder 12" tubing
• 00384707517031: Unistik ShieldLock 25G Safety Winged Set w/ Luer 8" tubing
• 00384707512036: Unistik ShieldLock 25G Safety Winged Sets w/ Luer 12" tubing
• 00384707322031: Unistik ShieldLock 23G Safety Winged Set w/ Luer and holder 12" tubing
• 00384707317037: Unistik ShieldLock 23G Safety Winged Set w/ Luer 8" tubing
• 00384707312032: Unistik ShieldLock 23G Safety Winged Sets w/ Luer 12" tubing
• 00384707122037: Unistik ShieldLock 21G Safety Winged Set w/ Luer and holder 12" tubing
• 00384707117033: Unistik ShieldLock 21G Safety Winged Set w/ Luer 8" tubing