IV Administration Set,Non-Toxic

GUDID 00840117335226

Sterile

DYNAREX CORPORATION

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• Primary Device ID: 00840117335226
• NIH Device Record Key: 5485ceb9-3aa7-475a-abb4-7e4afd9e27bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IV Administration Set,Non-Toxic
• Version Model Number: 7068
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117335226 [Package]; Contains: 00840117335240; Package: MC [50 Units]; In Commercial Distribution
GS1	00840117335240 [Primary]

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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-19
• Device Publish Date: 2024-03-11

Devices Manufactured by DYNAREX CORPORATION

• 08401173287854 - DynaCare Tampons,Super,Plastic Applicator: 2024-04-17 Unscented, Free of Dyes & Perfumes
• 00860008059512 - IV Start Kit: 2024-04-10
• 00840117333215 - Instant Cold Pack, 4" x 5": 2024-04-08 For use whenever instant cold therapy is required
• 00616784046617 - Homecare Half Length Bed Rail Cross Bar Mount: 2024-04-05
• 00616784706313 - IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic: 2024-04-02 15" , Sterile
• 00840117333000 - XeroBurn Sterile Burn Dressing Blanket: 2024-04-02 30" x 35"
• 00840117333024 - XeroBurn Sterile Burn Dressing Blanket 60"x 70": 2024-04-02 60"x 70"
• 00840117333048 - XeroBurn Sterile Burn Dressing Blanket 70" x 95": 2024-04-02 70" x 95"