CareSens S

GUDID 00385540109742

Glucose monitoring system IVD, home-use

Primary Device ID	00385540109742
NIH Device Record Key	4070304d-d53e-4e2b-8b03-4fb2bb9f3e2d
Commercial Distribution Status	In Commercial Distribution
Brand Name	CareSens S
Version Model Number	8000-10974
Company DUNS	156756129
Company Name	AGAMATRIX, INC.
Device Count	50
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00385540109742 [Package] Contains: 10385540109749 Package: Retail Carton [1 Units] In Commercial Distribution
GS1	00385540109766 [Package] Contains: 10385540109749 Package: Retail Carton [2 Units] In Commercial Distribution
GS1	08038554010970 [Unit of Use]
GS1	10385540109749 [Primary]
GS1	20385540109746 [Package] Package: Shipper [24 Units] In Commercial Distribution
GS1	20385540109760 [Package] Contains: 00385540109766 Package: Shipper [12 Units] In Commercial Distribution
GS1	30385540109743 [Package] Contains: 20385540109746 Package: Outer Shipper [20 Units] In Commercial Distribution
GS1	30385540109767 [Package] Contains: 20385540109760 Package: Outer Shipper [8 Units] In Commercial Distribution

NBW	System, Test, Blood Glucose, Over The Counter

Steralize Prior To Use	false
Device Is Sterile	false

00385540109742	CareSens S Test Strip 50ct Vial
20385540109753	CareSens S Control Solution