COULTER Latron 7546914

GUDID 15099590250683

COULTER LATRON Control

Beckman Coulter, Inc.

Non-blood cell primer/calibrator/control material IVD, reagent

• Primary Device ID: 15099590250683
• NIH Device Record Key: 4cbd3eff-07d5-46ca-ad55-442cad6157f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COULTER Latron
• Version Model Number: 7546914
• Catalog Number: 7546914
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590250683 [Primary]

FDA Product Code

• GKL: Counter, Cell, Automated (Particle Counter)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [COULTER Latron]

• 15099590250690: COULTER LATRON Primer
• 15099590250683: COULTER LATRON Control