IV Administration Set,Non-Toxic

GUDID 00840117335226

Sterile

DYNAREX CORPORATION

Intravenous administration tubing extension set

• 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	00840117335233 [Package]; Package: Shipper [4 Units]; In Commercial Distribution
GS1	00840117335240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210381

FDA Product Code

• FPA: Set, Administration, Intravascular
• LHI: Set, I.V. Fluid Transfer

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

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