Tyson Bio HT100 Blood Glucose Meter

GUDID 04719869705396

TYSON BIORESEARCH INC.

Glucose monitoring system IVD, home-use
Primary Device ID04719869705396
NIH Device Record Keyb64386ed-d604-4fa6-8e98-185a3c07814f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTyson Bio HT100 Blood Glucose Meter
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS104719869705396 [Primary]

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 Date2023-08-15
Device Publish Date2023-08-07

Devices Manufactured by TYSON BIORESEARCH INC.

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14719869702033 - Tyson Bio HS100 Blood Glucose Monitoring System 2023-09-04
14719869702095 - Tyson Bio HS100-B Blood Glucose Monitoring System 2023-09-04
04719869705396 - Tyson Bio HT100 Blood Glucose Meter2023-08-15
04719869705396 - Tyson Bio HT100 Blood Glucose Meter2023-08-15
14719869703221 - Tyson Bio HT100 Blood Glucose Monitoring System 2023-02-27
14719869703306 - Tyson Bio HT100-B Blood Glucose Monitoring System 2023-02-27
14719869704167 - Tyson Bio HT100-B Control Solution Level 32023-02-27

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