COULTER LH 723585

GUDID 15099590282431

COULTER LH 780 System

Beckman Coulter, Inc.

Haematological cell analyser IVD, automated Haematological cell analyser IVD, automated Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD

• Primary Device ID: 15099590282431
• NIH Device Record Key: 18e1aa3a-2661-4bcf-9de6-d896aded74d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COULTER LH
• Version Model Number: 780
• Catalog Number: 723585
• 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	15099590282431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061616

FDA Product Code

• GKZ: Counter, Differential Cell

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-23

On-Brand Devices [COULTER LH]

• 15099590317676: COULTER LH 500 Series System
• 15099590282431: COULTER LH 780 System
• 15099590265045: COULTER LH 500 Series System
• 15099590265038: COULTER LH 500 Series System
• 15099590264772: COULTER LH 750 System