Tyson Bio AC500 Blood Glucose Monitoring System

GUDID 14719869703481

TYSON BIORESEARCH INC.

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Primary Device ID14719869703481
NIH Device Record Keyac6dba45-cc2a-45f7-b127-8770a3ae00d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTyson Bio AC500 Blood Glucose Monitoring System
Version Model NumberAC500
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS104719869703484 [Primary]
GS114719869703481 [Package]
Contains: 04719869703484
Package: [80 Units]
In Commercial Distribution
GS124719869703488 [Package]
Contains: 04719869703484
Package: [72 Units]
Discontinued: 2022-04-07
Not 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 Date2020-04-23
Device Publish Date2020-04-15

On-Brand Devices [Tyson Bio AC500 Blood Glucose Monitoring System ]

14719869703498AC500
14719869703481AC500
14719869703108AC500
14719869703054AC500

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