BLE Smart® Test Strips

Basic Information

• Brand Name: BLE Smart® Test Strips
• Primary DI: 00850081003960
• Version / Model: BLE-TS50-FDA
• Company Name: ENTRA HEALTH SYSTEMS LLC
• Labeler DUNS: 826314044
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-27
• Public Version: 7
• Public Version Date: 2021-10-28
• Public Version Status: Update
• Public Device Record Key: 90497590-19cd-4b4f-bdb3-5fdd2d8e7f8a
• Distribution End Date: 2020-04-01

Device Description

Glucose Test Strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850081003960	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	0.5	Microliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit