AccessGUDID - DEVICE: Prodigy Pocket Blood Glucose Monitoring System (00384840503625)

GUDID

Device Identifier (DI) Information

Brand Name: Prodigy Pocket Blood Glucose Monitoring System
Version or Model: 050362
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 050362
Company Name: Prodigy Diabetes Care, LLC

Primary DI Number: 00384840503625
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832875905 *Terms of Use

Device Description: Prodigy Pocket Blood Glucose Monitoring System - Blue (KIT)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
30854	Home-use/point-of-care blood glucose monitoring system IVD	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 together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	Obsolete	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter
CGA	Glucose Oxidase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 517333be-524b-4860-afd6-cbe44f0acea2
Public Version Date: September 27, 2023
Public Version Number: 3
DI Record Publish Date: September 21, 2016