PRECICHEK AutoCode foil packed test strip

Basic Information

• Brand Name: PRECICHEK AutoCode foil packed test strip
• Primary DI: 04260236851111
• Version / Model: 3L-10-16003H
• Catalog Number: 3L-10-16003H
• Company Name: HMD BIOMEDICAL INC.
• Labeler DUNS: 658644174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-12
• Public Version: 1
• Public Version Date: 2020-05-20
• Public Version Status: New
• Public Device Record Key: 4be0f49c-4c3c-459d-b621-cb3bd5c623fa

Device Description

PRECICHEK AutoCode Blood Glucose ACH foil packed test strip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1
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
62538	Glucose monitoring system IVD, point-of-care	A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. 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	00389154000860	GS1	Foil	240	In Commercial Distribution
Primary	04260236851111	GS1

Premarket Submissions

Submission Number	Supplement Number
K120064	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity