Yumizen H2500

GUDID 03610230009451

HORIBA ABX SAS

Haematological cell analyser IVD

• Primary Device ID: 03610230009451
• NIH Device Record Key: dc5df249-0703-4d72-b7f5-726e333c87d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yumizen H2500
• Version Model Number: 1300102148
• 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	03610230009451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232946

FDA Product Code

• GKZ: Counter, Differential Cell

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: 2024-12-09
• Device Publish Date: 2024-11-29

On-Brand Devices [Yumizen H2500]

• 03610230009451: 1300102148
• 03610230009444: 1300102147