COULTER LH 723585

GUDID 15099590282431

COULTER LH 780 System

Beckman Coulter, Inc.

Haematological cell analyser IVD, automated

• 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