Tyson Bio HS200 Blood Glucose Monitoring System

GUDID 14719869702804

TYSON BIORESEARCH INC.

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Primary Device ID14719869702804
NIH Device Record Keyabbd974a-9a76-4d9e-babe-51554d12c407
Commercial Distribution StatusIn Commercial Distribution
Brand NameTyson Bio HS200 Blood Glucose Monitoring System
Version Model NumberHS200
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 Datetrue
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
GS104719869702807 [Primary]
GS114719869702804 [Package]
Contains: 04719869702807
Package: [72 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 Date2023-02-10
Device Publish Date2023-02-02

On-Brand Devices [Tyson Bio HS200 Blood Glucose Monitoring System ]

14719869702804HS200
14719869702781HS200

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