UA Win10 Kit C52900

GUDID 15099590735982

Urinalysis Win10 Kit with PC7 hardware

BECKMAN COULTER IRELAND INC.

Urine analyser IVD, laboratory, automated

• Primary Device ID: 15099590735982
• NIH Device Record Key: c1ee39b1-9547-47e9-b04a-52243b9f8e14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UA Win10 Kit
• Version Model Number: C52900
• Catalog Number: C52900
• Company DUNS: 985071975
• Company Name: BECKMAN COULTER IRELAND INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590735982 [Primary]

FDA Product Code

• KQO: Automated Urinalysis System

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: 2020-03-30
• Device Publish Date: 2020-03-20

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