Pharmacist's Choice 62850-0000-22

GUDID 10862850000220

Retail Blood Glucose Test Strips for Clever Choice HD and Voice HD Blood Glucose Meters.

SIMPLE DIAGNOSTICS INC

Glucose monitoring system IVD, home-use
Primary Device ID10862850000220
NIH Device Record Key0fb0b776-a8db-42f0-9ece-19d5b1ce02b4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePharmacist's Choice
Version Model NumberTest Strips - Retail
Catalog Number62850-0000-22
Company DUNS004135503
Company NameSIMPLE DIAGNOSTICS INC
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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

Phone1.877.342.2385
Emailcustomerservice@simplediagnost

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100862850000223 [Primary]
GS110862850000220 [Package]
Contains: 00862850000223
Package: Case [400 Units]
In Commercial Distribution
GS110862850000223 [Package]
Contains: 00862850000223
Package: Inner Case [40 Units]
In Commercial Distribution
GS120862850000223 [Package]
Contains: 10862850000223
Package: Outer Case [10 Units]
In Commercial Distribution
GS130862850000224 [Unit of Use]

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-12