Oracle

GUDID 04719871820216

Oracle Blood Glucose Monitoring System

BIOTEST MEDICAL CORPORATION

Glucose analyser IVD, home-use/point-of-care, line-powered

• Primary Device ID: 04719871820216
• NIH Device Record Key: 3f8abe6e-581b-4855-89c3-f9b7c1893a0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oracle
• Version Model Number: 6268(BM6B268ROA)
• Company DUNS: 658447255
• Company Name: BIOTEST MEDICAL CORPORATION
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-841-1109
• Email: Ben.Coffey@nurserosie.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719871820216 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2016-11-29

On-Brand Devices [Oracle]

• 04719871820292: Oracle Control Solution - Low(BYGOD11BT)
• 04719871820278: Oracle Control Solution - Medium(BYGOD21BT)
• 04719871820254: Oracle Control Solution- High(BYGOD31BT)
• 04719871820230: Oracle Blood Glucose Test Strip(BY8818G0NL4)
• 04719871820216: Oracle Blood Glucose Monitoring System