EZ Smart-608 Blood Glucose Test Strips (50T)

GUDID 24719869700661

TYSON BIORESEARCH INC.

Glucose IVD, kit, electrometry
Primary Device ID24719869700661
NIH Device Record Key23f79992-1e46-4f87-9f6e-8eec11ba637b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZ Smart-608 Blood Glucose Test Strips (50T)
Version Model NumberEZ Smart-608
Company DUNS658026104
Company NameTYSON BIORESEARCH INC.
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 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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719869700667 [Primary]
GS114719869700664 [Package]
Contains: 04719869700667
Package: [280 Units]
In Commercial Distribution
GS124719869700661 [Package]
Contains: 04719869700667
Package: [560 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-26

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