Advocate Redi- Code+ Test Strips for Blood Glucose 50 Count

Basic Information

• Brand Name: Advocate Redi- Code+ Test Strips for Blood Glucose 50 Count
• Primary DI: 00894046001578
• Version / Model: BMB002
• Catalog Number: BMB002
• Company Name: DIABETIC SUPPLY OF SUNCOAST, INC.
• Labeler DUNS: 043081723
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 5
• Public Version Date: 2022-11-01
• Public Version Status: Update
• Public Device Record Key: 5d79e786-ec44-4553-8e25-18988ce1833d

Device Description

Advocate Redi- Code+ Test Strips for accurate monitoring of blood glucose levels, 50 Count

Device Characteristics

• Single Use: No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBW	System, Test, Blood Glucose, Over The Counter	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
Package	10894046001575	GS1	BMB002-C	400	In Commercial Distribution
Package	20894046001572	GS1	BMB002-I	20	In Commercial Distribution
Primary	00894046001578	GS1
Unit of Use	30894046001579	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 0 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 0 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 39.2 – 104 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 4 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius