ORTHO CONNECT

GUDID 05060496770028

ORTHO CONNECT™ Software is designed to collect data from blood grouping and immunology assays, which allows operators to track individual patient and

STRATEC BIOMEDICAL UK LIMITED

Blood bank information system application software

• Primary Device ID: 05060496770028
• NIH Device Record Key: cee737c5-7245-4978-b8b1-da6d4a4d48e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO CONNECT
• Version Model Number: 2.0
• Company DUNS: 502054265
• Company Name: STRATEC BIOMEDICAL UK LIMITED
• 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: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060496770028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK160124

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: 1
• Public Version Date: 2018-11-02
• Device Publish Date: 2018-10-02

Devices Manufactured by STRATEC BIOMEDICAL UK LIMITED

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• 05060496770028 - ORTHO CONNECT: 2018-11-02ORTHO CONNECT™ Software is designed to collect data from blood grouping and immunology assays, which allows operators to track individual patient and
• 05060496770028 - ORTHO CONNECT: 2018-11-02 ORTHO CONNECT™ Software is designed to collect data from blood grouping and immunology assays, which allows operators to track
• 05060496770004 - cobas Synergy: 2018-10-19 cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample materi