Dead End Stopper & Cap

GUDID 00616784705736

DYNAREX CORPORATION

Intravenous line stopcock

• Primary Device ID: 00616784705736
• NIH Device Record Key: 2e8c73b3-70a6-43f8-884b-a0ff71597165
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dead End Stopper & Cap
• Version Model Number: 7057
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 200
• 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: false
• 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	00616784705712 [Unit of Use]
GS1	00616784705729 [Primary]
GS1	00616784705736 [Package]; Contains: 00616784705729; Package: [2000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172266

FDA Product Code

• FMG: Stopcock, I.V. Set

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: 2018-11-12
• Device Publish Date: 2018-10-10

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