MyGlucoHealth Lancets

GUDID 00850081003038

Blood lancet, single-use

Primary Device ID	00850081003038
NIH Device Record Key	bbeffaad-0d06-43ce-b349-ca6df85ca006
Commercial Distribution Status	In Commercial Distribution
Brand Name	MyGlucoHealth Lancets
Version Model Number	MGH-LCT100
Company DUNS	826314044
Company Name	ENTRA HEALTH SYSTEMS LLC
Device Count	1
DM Exempt	true
Pre-market Exempt	true
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	true
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	00850081003038 [Primary]

FMK	Lancet, Blood

Steralize Prior To Use	false
Device Is Sterile	true

10850081003011 - MyGlucoHealth Test Strips	2021-10-28 Glucose Test Strip Vial Label
10852668007016 - BLE Smart Test Strip	2021-10-28 BLE Smart Test Strip Vial
00852668007187 - BLE Smart® Control Solution	2019-02-22 Control Solution Box 3 Pack
00850081003960 - BLE Smart® Test Strips	2019-02-08 Glucose Test Strips
00852668007019 - BLE Smart® Test Strips	2019-02-05 Glucose Test Strips Unit of Use (each individual test strip)
00852668007064 - BLE Smart® Blood Glucose System	2019-02-05 Blood Glucose Meter Kit
00852668007071 - BLE Smart® Blood Glucose Meter	2019-02-05 Blood Glucose Meter Label
00852668007095 - MyGlucoHealth® BT Meter	2019-02-05 Blood Glucose meter (label)