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GUDID 00863398000294

Blood glucose meter.

LEXINGTON WELLNESS HOLDINGS INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00863398000294
• NIH Device Record Key: b0613c4c-0892-4980-87d5-b7f41e86086e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scan
• Version Model Number: G-427B
• Company DUNS: 079437338
• Company Name: LEXINGTON WELLNESS HOLDINGS 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• 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	00863398000294 [Primary]
GS1	20863398000298 [Package]; Package: Inner Pack [10 Units]; In Commercial Distribution
GS1	30863398000295 [Package]; Contains: 20863398000298; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191657

FDA Product Code

• CGA: Glucose Oxidase, Glucose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-09
• Device Publish Date: 2021-02-01

On-Brand Devices [Scan]

• 00863398000294: Blood glucose meter.
• 00860005561704: Blood glucose meter test strips.