CareSens S Fit

GUDID 20385540109722

CareSens S Fit System Kit

AGAMATRIX, INC.

Glucose monitoring system IVD, home-use
Primary Device ID20385540109722
NIH Device Record Key5131f7f4-08a0-4016-9807-8127740f73fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameCareSens S Fit
Version Model Number8000-10972
Company DUNS156756129
Company NameAGAMATRIX, 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 Batchtrue
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
GS100385540109728 [Primary]
GS120385540109722 [Package]
Contains: 00385540109728
Package: Shipper [12 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 Date2025-08-12
Device Publish Date2025-08-04

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