642E Centrifuge, CME 00-018-252-000

GUDID 00810052863535

General purpose laboratory centrifuge for sample separation.

DRUCKER DIAGNOSTICS

General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD General-purpose centrifuge IVD

• Primary Device ID: 00810052863535
• NIH Device Record Key: e5ceed7f-b045-42a5-9c12-3b8d94336601
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 642E Centrifuge, CME
• Version Model Number: 00-018-252-000
• Catalog Number: 00-018-252-000
• Company DUNS: 022156957
• Company Name: DRUCKER DIAGNOSTICS
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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	00810052863535 [Primary]

FDA Product Code

• JQC: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

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: 2023-02-23
• Device Publish Date: 2023-02-15

Devices Manufactured by DRUCKER DIAGNOSTICS

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• 00810052864150 - Horizon 6 DC Centrifuge, Drucker: 2024-03-26 General purpose laboratory centrifuge for sample separation.
• 00810052864167 - Horizon 6 FA DC Centrifuge, Drucker: 2024-03-26 General purpose laboratory centrifuge for sample separation.
• 00810052864129 - Horizon 6 DC Centrifuge, Woodley: 2024-02-28 General purpose laboratory centrifuge for sample separation.