COULTER AcT 6706366

GUDID 15099590264734

COULTER Ac·T diff Analyzer

Beckman Coulter, Inc.

Haematological cell analyser IVD, automated

• Primary Device ID: 15099590264734
• NIH Device Record Key: ba9b3d0c-3b1b-491b-b709-cfebfad02738
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COULTER AcT
• Version Model Number: diff 12, diff 16
• Catalog Number: 6706366
• 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	15099590264734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973634

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 AcT]

• 15099590639426: COULTER Ac·T 5diff Cal Calibrator
• 15099590639419: COULTER Ac·T 5diff Control Plus
• 15099590579005: COULTER Ac·T 5diff Cap Pierce Hematology Analyzer
• 15099590578787: COULTER Ac·T 5diff Hematology Analyzer
• 15099590576479: COULTER Ac·T 5diff Autoloader Hematology Analyzer
• 15099590576462: COULTER Ac·T 5diff Hematology Analyzer
• 15099590264796: COULTER Ac·T diff 2 Analyzer
• 15099590264734: COULTER Ac·T diff Analyzer