AccessGUDID - DEVICE: ODM (00883489001504)

GUDID

Device Identifier (DI) Information

Brand Name: ODM
Version or Model: iGlucose Blood Glucose Monitoring System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 99GM291I01
Company Name: BIONIME CORPORATION

Primary DI Number: 00883489001504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658637244 *Terms of Use

Device Description: The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control solution(00883489001580),10 pcs/set of lancet(Sterile)(00883489001597) and 10 pcs/vial of strips_iGlucose Strip(00883489001573).

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:	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?
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
CGA	Glucose Oxidase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161790	000

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
Device Size Text, specify: Meter Dimensions 104 mm × 49.8 mm × 16.5 mm

Device Record Status

Public Device Record Key: 24bd8864-462f-451d-80ea-dc478ffab99e
Public Version Date: January 06, 2020
Public Version Number: 4
DI Record Publish Date: July 19, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00883489001580	1	00883489001504		In Commercial Distribution	combo
00883489001573	10	00883489001504		In Commercial Distribution	combo
00883489001566	1	00883489001504		In Commercial Distribution	combo
00883489001511	1	00883489001504		In Commercial Distribution	box
20883489001515	40	00883489001511	2020-01-03	Not in Commercial Distribution	carton
00883489001597	10	00883489001504		In Commercial Distribution	combo
10883489001518	6	00883489001511		In Commercial Distribution	paper box
20883489001508	8	10883489001518		In Commercial Distribution	paper carton