ReliOn™ Premier Classic Meter

GUDID 10681131280621

The ReliOn Premier Classic Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.

WAL-MART STORES, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10681131280621
• NIH Device Record Key: 2e62c0a4-7029-4ce4-865a-0fe3113a70d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReliOn™ Premier Classic Meter
• Version Model Number: 784001
• Company DUNS: 051957769
• Company Name: WAL-MART STORES, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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

Customer Support Contacts

• Phone: 1-855-776-0662
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681131280624 [Primary]
GS1	10681131280621 [Package]; Contains: 00681131280624; Package: Case Pack [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121133

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-29
• Device Publish Date: 2019-08-21

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