Rem Systems

GUDID 00813153025406

200 Micron Filter Unit for Stem Cell Infusions

CODAN US CORPORATION

Intravenous administration set

• Primary Device ID: 00813153025406
• NIH Device Record Key: a756ce7b-f1f0-43bf-ab11-9f8d4438be0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rem Systems
• Version Model Number: B 860SC
• Company DUNS: 058027475
• Company Name: CODAN US 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813153025406 [Package]; Contains: 10813153025403; Package: [1 Units]; In Commercial Distribution
GS1	10813153025403 [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: 2020-11-09
• Device Publish Date: 2020-10-31

On-Brand Devices [Rem Systems]

• 00813153025406: 200 Micron Filter Unit for Stem Cell Infusions
• 00813153026557: Extension Set with Ultra-Clear Valve
• 00897891001588: Blood Set with Stopcock, Check Valve & Needlefree Valve