Portable Blood Glucose Meter

Portable Blood Glucose Meter
ASSURE® PRISM MULTI BLOOD GLUCOSE METER - 530001

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 Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NBW

Device Name: System, Test, Blood Glucose, Over The Counter

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1345

Third Party Flag: N

Medical Specialty: CH

Device Id: 20015482530017

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00015482530013

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Master Case Shipper

Device Id: 00015482530013

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 30015482530014

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00015482530013

Package Quantity: 40

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Master Case Shipper