ReliOn® Prime Blood Glucose Test Strips

GUDID 10605388022940

Blood Glucose Test Strips

WAL-MART STORES, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10605388022940
• NIH Device Record Key: 0e76da1c-5403-4e01-8200-f9c8d5036c20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReliOn® Prime Blood Glucose Test Strips
• Version Model Number: 700050 / 700100
• Company DUNS: 051957769
• Company Name: WAL-MART STORES, INC.
• Device Count: 50
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00605388022943 [Primary]
GS1	00681131078221 [Package]; Contains: 00605388022943; Package: Carton [2 Units]
GS1	10605388022940 [Package]; Contains: 00605388022943; Package: Case Pack [12 Units]; In Commercial Distribution
GS1	10681131078228 [Package]; Contains: 00681131078221; Package: Case Pack [6 Units]
GS1	50605388022948 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091102

FDA Product Code

• CGA: GLUCOSE OXIDASE, GLUCOSE

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: 2017-02-17

On-Brand Devices [ReliOn® Prime Blood Glucose Test Strips]

• 10605388022940: Blood Glucose Test Strips
• 10681131130339: Blood Glucose Test Strips