Easy Plus II

GUDID 04719871820063

Easy Plus II Glucose Meter, 6276-S

BIOTEST MEDICAL CORPORATION

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

• Primary Device ID: 04719871820063
• NIH Device Record Key: ae121415-9db3-4083-9f74-2944d0dad1c4
• Commercial Distribution Discontinuation: 2016-05-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Easy Plus II
• Version Model Number: 6276-S(BYG60276HA)
• Company DUNS: 658447255
• Company Name: BIOTEST MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719871820063 [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: 2016-05-02

On-Brand Devices [Easy Plus II]

• 04719871820124: Easy Plus II Control Solution Kit-Low
• 04719871820117: Easy Plus II Control Solution Kit-High
• 04719871820100: Easy Plus II Test Strip 25x2
• 04719871820094: Easy Plus II Control Solution-Low
• 04719871820087: Easy Plus II Control Solution-High
• 04719871820070: Easy Plus II Blood Glucose Test Strip
• 04719871820063: Easy Plus II Glucose Meter, 6276-S
• 04719871820056: Easy Plus II Blood Glucose Monitoring System 6276-S