ReliOn Ultima 70055

GUDID 30681131060289

Relion Utlima Blood Glucose Monitoring System

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 ID30681131060289
NIH Device Record Key2cd7ff8b-703f-4d1e-8469-a704c83f9116
Commercial Distribution StatusIn Commercial Distribution
Brand NameReliOn Ultima
Version Model Number70055
Catalog Number70055
Company DUNS051957769
Company NameWAL-MART STORES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx
Phone+1(855)776-0662
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100681131060288 [Primary]
GS130681131060289 [Package]
Contains: 00681131060288
Package: Case [4 Units]
In Commercial Distribution
NDC/NHRIC66004-6028-1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (specified) analyte controls (assayed and unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-26
Device Publish Date2016-09-16

On-Brand Devices [ReliOn Ultima]

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

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