Fresenius KABI AG

GUDID 00085003886301

8" High Pressure Extension Set with pinch clamp, male luer lock and bonded needleless connector

Directmed, Inc.

Intravenous administration tubing extension set

• Primary Device ID: 00085003886301
• NIH Device Record Key: 558265d5-ffb8-4490-bea2-4a4d936da75f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fresenius KABI AG
• Version Model Number: FK20203E
• Company DUNS: 969484237
• Company Name: Directmed, Inc.
• 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	00085003886301 [Package]; Contains: 00850038863012; Package: Each [1 Units]; In Commercial Distribution
GS1	00850038863012 [Primary]

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: 2023-11-01
• Device Publish Date: 2023-10-24

On-Brand Devices [Fresenius KABI AG]

• 10850038863019: 8" High Pressure Extension Set with pinch clamp, male luer lock and bonded needleless connector
• 00085003886301: 8" High Pressure Extension Set with pinch clamp, male luer lock and bonded needleless connector