IV Extension Set, 36"

GUDID 00616784706511

DYNAREX CORPORATION

Intravenous administration tubing extension set

• Primary Device ID: 00616784706511
• NIH Device Record Key: 14b38ca8-dd0e-474b-9c3d-50c72663f368
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IV Extension Set, 36"
• Version Model Number: 7065
• 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	00616784706511 [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: 2018-05-26

Devices Manufactured by DYNAREX CORPORATION

• 00840117321915 - DMECare Solutions Ever-Soft Lumbar Support Cushion,18": 2025-09-01 Weight Capacity: 350 LB.
• 00840117321939 - DMECare Solutions Ever-Soft Lumbar Support Cushion, 20": 2025-09-01 Weight Capacity: 350 LB.
• 00840117321953 - DMECare Solutions Ever-Soft Lumbar Support Cushion, 22": 2025-09-01 Weight Capacity: 350 LB.
• 00616784470429 - IV Start Kit with Nitrile Gloves, Sterile-EO: 2025-08-27
• 00616784704111 - IV Adminstration Set, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704210 - IV Administration Sets, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704418 - IV Administration Set, 20 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784304113 - Dmecare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 16"x16". Weight Capacity: 300 LB.