IV Administration Set, Non-Toxic

GUDID 00840117327504

10 mL

DYNAREX CORPORATION

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• Primary Device ID: 00840117327504
• NIH Device Record Key: 24c89da1-dfe3-4465-9705-b970bd482801
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IV Administration Set, Non-Toxic
• Version Model Number: 7029
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117327504 [Package]; Contains: 00840117327634; Package: Case [40 Units]; In Commercial Distribution
GS1	00840117327627 [Package]; Package: SH [6 Units]; In Commercial Distribution
GS1	00840117327634 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-05
• Device Publish Date: 2023-12-28

On-Brand Devices [IV Administration Set, Non-Toxic ]

• 00616784704517: Sterile
• 00840117327504: 10 mL