MINOTROL CRP 5302042207

GUDID 00856605006134

Whole Blood Hematology Control

HORIBA INSTRUMENTS INCORPORATED

Full blood count IVD, control

• Primary Device ID: 00856605006134
• NIH Device Record Key: 29093f56-81c0-42ea-a2b0-76a045eab413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINOTROL CRP
• Version Model Number: 2x2.5mL High
• Catalog Number: 5302042207
• Company DUNS: 052845583
• Company Name: HORIBA INSTRUMENTS INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856605006134 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-15

On-Brand Devices [MINOTROL CRP]

• 00856605006134: Whole Blood Hematology Control
• 00856605006127: Whole Blood Hematology Control
• 00856605006110: Whole Blood Hematology Control