IV Extension Set

GUDID 00616784706030

DYNAREX CORPORATION

Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: 00616784706030
• NIH Device Record Key: d6ae2035-2e5a-4a5a-8948-f8bcadc92935
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IV Extension Set
• Version Model Number: 7060
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 100
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784706016 [Unit of Use]
GS1	00616784706023 [Primary]
GS1	00616784706030 [Package]; Contains: 00616784706023; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012189

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

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: 2019-04-10
• Device Publish Date: 2016-09-24

On-Brand Devices [IV Extension Set]

• 00616784706238: 7061
• 00616784706139: 7061
• 00616784706030: 7060