DxH 900 Hematology System

GUDID 15099590701574

UniCel DxH 900 Coulter Cellular Analysis System

Beckman Coulter, Inc.

Haematological cell analyser IVD, automated

• Primary Device ID: 15099590701574
• NIH Device Record Key: ea97262c-d4b5-44e3-80d8-f5bc2fb0a5a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxH 900 Hematology System
• Version Model Number: C11478
• Company DUNS: 008254708
• Company Name: Beckman Coulter, 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	15099590701574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140911

FDA Product Code

• GKZ: Counter, Differential Cell

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-05-03

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