DxH 500 B40601

GUDID 15099590671242

DxH 500

BECKMAN COULTER IRELAND INC.

Haematological cell analyser IVD, automated

• Primary Device ID: 15099590671242
• NIH Device Record Key: 201127b2-d585-48a7-a8c0-d91c2f449389
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxH 500
• Version Model Number: B40601
• Catalog Number: B40601
• Company DUNS: 985071975
• Company Name: BECKMAN COULTER IRELAND INC.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590671242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181475

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: 2020-09-08
• Device Publish Date: 2020-08-31

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