FifthPulse

Basic Information

• Brand Name: FifthPulse
• Primary DI: 00850028714508
• Version / Model: FP100-L
• Company Name: Jeg & Sons Inc.
• Labeler DUNS: 789973646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-07-01
• Public Version: 1
• Public Version Date: 2021-07-09
• Public Version Status: New
• Public Device Record Key: dd73ad37-0906-4c96-bc34-d0da25d12279

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: 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
63085	Glucose rapid test/blood pressure system analyser, home-use	A portable, electrically-powered instrument used with other devices (e.g., reagents, test strips, a blood pressure cuff, and accessories) intended to be used 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. The measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810084930618	GS1
Primary	00850028714508	GS1