Yumizen C1200 AL 3200675839/3200685493

GUDID 03610230009253

AC 220V Class2 Laser Product + AC100V This device is a combination between the Yumizen C1200 (CA-20151BM6010C) and the autoloader RAmini (CA-21391RAMINI).

HORIBA ABX SAS

Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory

• Primary Device ID: 03610230009253
• NIH Device Record Key: 705344e2-edcd-4f32-9dfb-6e09892d2ff9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yumizen C1200 AL
• Version Model Number: CA-20151BM6010C/CA-21391RAMINI
• Catalog Number: 3200675839/3200685493
• Company DUNS: 273647420
• Company Name: HORIBA ABX SAS
• 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: 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	03610230009253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183375

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-09-16
• Device Publish Date: 2021-02-16

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