On Call Express Blood Glucose Monitoring System

Basic Information

• Brand Name: On Call Express Blood Glucose Monitoring System
• Primary DI: 00024291121831
• Version / Model: G115-10D
• Company Name: NAVAJO MANUFACTURING COMPANY
• Labeler DUNS: 136941411
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-30
• Public Version: 2
• Public Version Date: 2023-07-13
• Public Version Status: Update
• Public Device Record Key: 4a3b43f7-7933-4605-b221-aff18d1729ff
• Distribution End Date: 2022-10-05

Device Description

Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• 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: No
• 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
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
JJX	Single (specified) analyte controls (assayed and unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63087	Blood glucose/blood pressure monitoring system, home-use	A collection of devices intended for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10024291121838	GS1	CARTON	3	Not in Commercial Distribution	2022-10-05
Primary	00024291121831	GS1
Package	20024291121835	GS1	CASE	8	Not in Commercial Distribution	2022-10-05

Customer Contacts

• Phone: [phone] ext. 8265
• Email: [email protected]