COULTER S-CAL 628026

GUDID 15099590233761

COULTER S-CAL Calibrator Kit

Beckman Coulter, Inc.

Full blood count IVD, calibrator Full blood count IVD, calibrator

• Primary Device ID: 15099590233761
• NIH Device Record Key: 67475ff6-bc16-41d0-8443-2615f88cf7dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COULTER S-CAL
• Version Model Number: 628026
• Catalog Number: 628026
• 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	15099590233761 [Primary]

FDA Product Code

• KRY: Calibrator For Platelet Counting

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 S-CAL ]

• 15099590233761: COULTER S-CAL Calibrator Kit
• 15099590233679: COULTER S-CAL Calibrator Kit
• 15099590221881: COULTER S-CAL Calibrator Kit