PurCel Labs Easy Result Blood Glucose Meter

GUDID 00810143550153

Portable Blood Glucose Meter

Purcel Labs LLC

Glucose monitoring system IVD, home-use
Primary Device ID00810143550153
NIH Device Record Key393b0634-bfb6-421f-aa96-b9a037d0a605
Commercial Distribution StatusIn Commercial Distribution
Brand NamePurCel Labs Easy Result Blood Glucose Meter
Version Model Number1130
Company DUNS127672531
Company NamePurcel Labs LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810143550153 [Primary]
GS100810143550160 [Package]
Package: Case [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-28
Device Publish Date2023-07-20

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