MINOTROL 16 5300000277

GUDID 00856605006011

Whole Blood Hematology Control

HORIBA INSTRUMENTS INCORPORATED

Full blood count IVD, control

• Primary Device ID: 00856605006011
• NIH Device Record Key: d85d0130-bc5b-4e36-8266-3de4e4f9bb87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINOTROL 16
• Version Model Number: 3x2.5mL
• Catalog Number: 5300000277
• 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	00856605006011 [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: 2016-08-03

On-Brand Devices [MINOTROL 16]

• 00856605006035: Whole Blood Hematology Control
• 00856605006028: Whole Blood Hematology Control
• 00856605006011: Whole Blood Hematology Control