Rem Systems

GUDID 00897891001588

Blood Set with Stopcock, Check Valve & Needlefree Valve

CODAN US CORPORATION

Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set

• Primary Device ID: 00897891001588
• NIH Device Record Key: 59ea9a0c-0475-4a89-a15c-56a45679704b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rem Systems
• Version Model Number: B 898
• 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	00897891001588 [Package]; Contains: 10897891001585; Package: [1 Units]; In Commercial Distribution
GS1	10897891001585 [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: 2021-05-10
• Device Publish Date: 2021-04-30

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