BLE Smart® Control Solution

Basic Information

• Brand Name: BLE Smart® Control Solution
• Primary DI: 00852668007187
• Version / Model: BLE-CS3
• 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: 2018-11-20
• Public Version: 4
• Public Version Date: 2021-10-28
• Public Version Status: Update
• Public Device Record Key: 772d31e6-9598-44cc-a24e-900a2c714ecf
• Distribution End Date: 2020-04-01

Device Description

Control Solution Box 3 Pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852668007187	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 46 – 86 Degrees Fahrenheit