Yumizen C1200 Glucose HK

GUDID 03610230007013

R1= 6x39mL R2= 6x13mL

HORIBA ABX SAS

Glucose IVD, kit, enzyme spectrophotometry

• Primary Device ID: 03610230007013
• NIH Device Record Key: c81d73d4-dab7-4740-9ce2-b7eb073d9fe6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yumizen C1200 Glucose HK
• Version Model Number: 1300023848
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	03610230007013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183375

FDA Product Code

• CFR: Hexokinase, Glucose

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: 2020-05-14
• Device Publish Date: 2020-05-06

On-Brand Devices [Yumizen C1200 Glucose HK]

• 03610230007020: R1= 4x57mL R2= 3x26mL
• 03610230007013: R1= 6x39mL R2= 6x13mL