ReliOn® Prime Blood Glucose Monitoring System

GUDID 10605388022933

Portable Blood Glucose Meter

WAL-MART STORES, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10605388022933
• NIH Device Record Key: 4b18dbcb-6abc-4c5d-aca6-7e9a6f38a9ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReliOn® Prime Blood Glucose Monitoring System
• Version Model Number: 701103
• 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	00605388022936 [Primary]
GS1	10605388022933 [Package]; Contains: 00605388022936; Package: Case Pack [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091102

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: 2016-08-31

On-Brand Devices [ReliOn® Prime Blood Glucose Monitoring System]

• 10605388022933: Portable Blood Glucose Meter
• 10605388022926: Portable Blood Glucose Meter