AccessGUDID - DEVICE: Prodigy No Coding Blood Glucose Test Strips (00384840104006)

GUDID

Device Identifier (DI) Information

Brand Name: Prodigy No Coding Blood Glucose Test Strips
Version or Model: 010400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 010400
Company Name: Prodigy Diabetes Care, LLC

Primary DI Number: 00384840104006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832875905 *Terms of Use

Device Description: 1 Box of Prodigy No Coding Blood Glucose Test Strips for eCommerce (50 ct)

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
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?
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
CGA	Glucose Oxidase, Glucose
NBW	System, Test, Blood Glucose, Over The Counter

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: 3a4171a7-e5cc-44d5-bc7d-801a946ff3d5
Public Version Date: July 18, 2024
Public Version Number: 1
DI Record Publish Date: July 10, 2024