IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic

GUDID 00616784706313

15" , Sterile

DYNAREX CORPORATION

Intravenous administration tubing extension set

• Primary Device ID: 00616784706313
• NIH Device Record Key: 4ab3eb40-f5d0-4e03-b49c-14e7fe01d35b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic
• Version Model Number: 7063
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00616784706313 [Primary]
GS1	00616784706320 [Package]; Package: Box [100 Units]; In Commercial Distribution
GS1	00616784706337 [Package]; Contains: 00616784706320; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210381

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2024-04-02
• Device Publish Date: 2024-03-25

Devices Manufactured by DYNAREX CORPORATION

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• 00840117312906 - Resp-O2 Endotracheal Tube Cuffed, 4.0 mm: 2024-11-01 Sterile-EO
• 00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm: 2024-11-01 Sterile-EO
• 00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm: 2024-11-01 Sterile-EO
• 00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm: 2024-11-01 Sterile-Eo
• 00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm: 2024-11-01 Sterile-Eo
• 00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm: 2024-11-01 Sterile-Eo