POPS! one Blood Glucose Monitoring System

GUDID 04713106029788

POPS! DIABETES CARE, INC.

Glucose analyser IVD, home-use
Primary Device ID04713106029788
NIH Device Record Key996fb0c8-e957-4ee6-8dcd-62bfbbf27e30
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOPS! one Blood Glucose Monitoring System
Version Model NumberTD-4142
Company DUNS053522562
Company NamePOPS! DIABETES CARE, 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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104713106029788 [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 Date2019-02-28
Device Publish Date2019-01-28

On-Brand Devices [POPS! one Blood Glucose Monitoring System]

04713106029788TD-4142
00860421000498TD-4142

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