BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Assure® Prism Multi Blood Glucose Meter

DI: 30015482531776 · Model: 531177 · ARKRAY USA, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Assure® Prism Multi Blood Glucose Meter
Primary DI: 30015482531776
Version / Model: 531177
Company Name: ARKRAY USA, INC.
Labeler DUNS: 008171162
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2022-06-17
Public Version: 2
Public Version Date: 2025-03-19
Public Version Status: Update
Public Device Record Key: 338ce6a1-59f1-4ec9-afc3-84bf51f712a3
Distribution End Date: 2025-03-18

Device Description

Assure Prism Meter Institutional multi-pack (4 Assure Prism meter kits PN 530001)

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: Yes
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: No
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

GMDN Terms

Code	Name	Definition	Implantable	Status
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; 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. 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
Primary	30015482531776	GS1

Customer Contacts

Phone: +1(800)818-8877
Email: [email protected]

Storage Conditions

Type: Handling Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: 50 – 104 Degrees Fahrenheit