ReliOn™ Premier BLU Basic Meter (or Monitoring System)

GUDID 10681131169803

The ReliOn Premier BLU Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. ReliOn Premier BLU is a full feature blood glucose monitoring system featuring Bluetooth Smart technology. Wireless Bluetooth technology connects the meter to a cloud based portal through ReliOn Life app you download onto your smart phone.

WAL-MART STORES, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10681131169803
• NIH Device Record Key: 63087126-d2f2-44e4-b251-ac8b56ece962
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReliOn™ Premier BLU Basic Meter (or Monitoring System)
• Version Model Number: 782001
• 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
• Phone: 1-855-776-0662
• Email: xxx@xxx.xxx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681131169806 [Primary]
GS1	10681131169803 [Package]; Contains: 00681131169806; Package: Case Shipper [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170614

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-18

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