AccessGUDID - DEVICE: FortisCare Self-Monitoring Blood Glucose System (00885017000461)

GUDID

Device Identifier (DI) Information

Brand Name: FortisCare Self-Monitoring Blood Glucose System
Version or Model: EM66
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EPS BIO TECHNOLOGY CORP.

Primary DI Number: 00885017000461
Issuing Agency: GS1
Commercial Distribution End Date: July 25, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 658620117 *Terms of Use

Device Description: 1 blood glucose meter; 10 strips in a vial; level 2 control solution in a convenience 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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
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.	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
Storage Environment Temperature: between 2 and 30 Degrees Celsius
Handling Environment Humidity: less than 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 40 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ecef23a2-41e5-4546-8555-28363b93a42f
Public Version Date: August 07, 2024
Public Version Number: 4
DI Record Publish Date: July 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
01885017000460	10	00885017000461	2016-07-25	Not in Commercial Distribution	carton
10885017000468	10	00885017000461	2016-07-25	Not in Commercial Distribution	carton