Tyson Bio HT100 Blood Glucose Monitoring System

GUDID 14719869701791

TYSON BIORESEARCH INC.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use
Primary Device ID14719869701791
NIH Device Record Key478d8ab6-655d-4047-b34e-47c116cdf865
Commercial Distribution StatusIn Commercial Distribution
Brand NameTyson Bio HT100 Blood Glucose Monitoring System
Version Model NumberHT100
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
GS104719869701794 [Primary]
GS114719869701791 [Package]
Contains: 04719869701794
Package: [80 Units]
In Commercial Distribution
GS124719869701798 [Package]
Contains: 04719869701794
Package: [72 Units]
In Commercial Distribution
GS134719869701825 [Package]
Contains: 04719869701794
Package: [250 Units]
In Commercial Distribution
GS144719869701822 [Package]
Contains: 04719869701794
Package: [500 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 Date2018-08-17
Device Publish Date2018-07-17

On-Brand Devices [Tyson Bio HT100 Blood Glucose Monitoring System ]

14719869701791HT100
14719869703016HT100
14719869703221HT100

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