BLE Smart® Test Strips

GUDID 00852668007019

Glucose monitoring system IVD, home-use

Primary Device ID	00852668007019
NIH Device Record Key	3355bd4f-9e41-4de8-a2a0-5b6111989db5
Commercial Distribution Status	In Commercial Distribution
Brand Name	BLE Smart® Test Strips
Version Model Number	BLE-TS50-FDA
Company DUNS	826314044
Company Name	ENTRA HEALTH SYSTEMS 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	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

Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00852668007019 [Primary]

CGA	Glucose Oxidase, Glucose

Steralize Prior To Use	false
Device Is Sterile	false

00852668007019	Glucose Test Strips Unit of Use (each individual test strip)
00850081003960	Glucose Test Strips