IV Adminstration Set

GUDID 00616784704128

DYNAREX CORPORATION

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• Primary Device ID: 00616784704128
• NIH Device Record Key: 115a91b9-5d1d-468b-8b6a-4307c67099cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IV Adminstration Set
• Version Model Number: 7041
• 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	00616784704128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083687

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-01-06

On-Brand Devices [IV Adminstration Set]

• 00616784704623: 7046
• 00616784704128: 7041