ReliOn Ultima 70055

GUDID 30681131060289

Relion Utlima Blood Glucose Monitoring System

WAL-MART STORES, INC.

Glucose/ketone monitoring system IVD, home-use

• Primary Device ID: 30681131060289
• NIH Device Record Key: 2cd7ff8b-703f-4d1e-8469-a704c83f9116
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReliOn Ultima
• Version Model Number: 70055
• Catalog Number: 70055
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx
• Phone: +1(855)776-0662
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681131060288 [Primary]
GS1	30681131060289 [Package]; Contains: 00681131060288; Package: Case [4 Units]; In Commercial Distribution
NDC/NHRIC	66004-6028-1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083223

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-26
• Device Publish Date: 2016-09-16

On-Brand Devices [ReliOn Ultima]

• 30681131060319: ReliOn Ultima Blood Glucose Test Strips
• 30681131060302: Relion Ultima Blood Glucose Test Strips
• 30681131060296: ReliOn Ultima Blood Glucose Test Strips
• 30681131060289: Relion Utlima Blood Glucose Monitoring System