AccessGUDID - DEVICE: On Call Express Blood Glucose Monitor (00024291121824)

GUDID

Device Identifier (DI) Information

Brand Name: On Call Express Blood Glucose Monitor
Version or Model: G115-11D
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NAVAJO MANUFACTURING COMPANY

Primary DI Number: 00024291121824
Issuing Agency: GS1
Commercial Distribution End Date: October 17, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 136941411 *Terms of Use

Device Description: Blood Glucose Meter

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:	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?
63087	Blood glucose/blood pressure monitoring system, home-use	A collection of devices intended for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure; 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. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 532b8c3c-0abe-4a37-87c6-0955b9d994ea
Public Version Date: July 13, 2023
Public Version Number: 2
DI Record Publish Date: March 30, 2020