ReliOn Ultima 70121

GUDID 30681131060302

Relion Ultima Blood Glucose Test Strips

WAL-MART STORES, INC.

Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use

• Primary Device ID: 30681131060302
• NIH Device Record Key: 8e29a36f-7ed5-4965-b4c5-8e7abf2ef720
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReliOn Ultima
• Version Model Number: 70121
• Catalog Number: 70121
• 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: 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 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• 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	00681131060301 [Primary]
GS1	10681131060308 [Unit of Use]
GS1	30681131060302 [Package]; Contains: 00681131060301; Package: Case [12 Units]; In Commercial Distribution
NDC/NHRIC	66004-6030-4 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083223

FDA Product Code

• LFR: Glucose dehydrogenase, 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: 2018-02-05

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