Echo Lumena 0086998

GUDID 10888234002338

The Echo Lumena is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The

IMMUCOR, INC.

Immunohaematology/blood bank analyser IVD, automated Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD Immunohaematology/blood bank analyser IVD

• Primary Device ID: 10888234002338
• NIH Device Record Key: cf9b8944-69a2-44a4-8bb9-fd723d5bc91a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echo Lumena
• Version Model Number: 0086998
• Catalog Number: 0086998
• Company DUNS: 061446282
• Company Name: IMMUCOR, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com
• Phone: 1-855-466-8267
• Email: tech_support@immucor.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.
• Special Storage Condition, Specify: Between 0 and 0 *This is an automated laboratory instrument.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234002338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK170135

FDA Product Code

• KSZ: System, Test, Automated Blood Grouping And Antibody

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-01

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