Lucidplus Glucose Test strips 50 count

GUDID 00851225008032

VIDAN DIAGNOSTICS LLC

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Primary Device ID	00851225008032
NIH Device Record Key	d0137ca0-ce8e-489d-b4c1-f5065fdde50b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Lucidplus Glucose Test strips 50 count
Version Model Number	2100-050
Company DUNS	092729952
Company Name	VIDAN DIAGNOSTICS LLC
Device Count	1
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	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851225008032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161738

FDA Product Code

LFR	Glucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-01-04
Device Publish Date	2018-12-04

Devices Manufactured by VIDAN DIAGNOSTICS LLC

00851225008001 - LucidPlus B-Ketone Plus Blood Glucose Monitoring System	2019-12-11
00851225008025 - Lucidplus B-Ketone Test Strips 50 count	2019-01-07
00851225008032 - Lucidplus Glucose Test strips 50 count	2019-01-04
00851225008032 - Lucidplus Glucose Test strips 50 count	2019-01-04