COULTER 4C Plus 7547114

GUDID 15099590225216

COULTER 4C Plus Cell Control

Beckman Coulter, Inc.

Full blood count IVD, control Full blood count IVD, control

• Primary Device ID: 15099590225216
• NIH Device Record Key: 0482d0b1-45f3-4a11-a7ce-85444b12ba53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COULTER 4C Plus
• Version Model Number: 7547114
• Catalog Number: 7547114
• 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 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590225216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955016

FDA Product Code

• JPK: Mixture, Hematology Quality Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [COULTER 4C Plus]

• 15099590230302: COULTER 4C Plus Cell Control
• 15099590225216: COULTER 4C Plus Cell Control