COULTER Retic-C 7546979

GUDID 15099590221119

COULTER Retic-C Cell Control

Beckman Coulter, Inc.

Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control Reticulocyte count IVD, control

• Primary Device ID: 15099590221119
• NIH Device Record Key: e1115f07-f2a6-4473-ad2f-6c701890df92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COULTER Retic-C
• Version Model Number: 7546979
• Catalog Number: 7546979
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• 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	15099590221119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930119

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 Retic-C ]

• 15099590231026: COULTER Retic-C Cell Control
• 15099590230395: COULTER Retic-C Cell Control
• 15099590221119: COULTER Retic-C Cell Control