Blood Glucose Monitoring System LIVE TULA

GUDID 00860012134007

TULA HEALTH, INC.

Glucose analyser IVD, home-use
Primary Device ID00860012134007
NIH Device Record Key9ac98349-1e82-4ba8-bf57-86f1816c5d12
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlood Glucose Monitoring System LIVE TULA
Version Model NumberTD-4266
Company DUNS062385494
Company NameTULA HEALTH, 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 Usefalse
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860012134007 [Primary]

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 Date2024-06-24
Device Publish Date2024-06-15

Devices Manufactured by TULA HEALTH, INC.

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00860012134007 - Blood Glucose Monitoring System LIVE TULA 2024-06-24
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00860012134021 - Blood Glucose Test Strips (50pcs/box) LIVE TULA2024-06-24

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