AccessGUDID - DEVICE: GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT) (04711200722291)

GUDID

Device Identifier (DI) Information

Brand Name: GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT)
Version or Model: 3S-01-14010J
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3S-01-14010J
Company Name: HMD BIOMEDICAL INC.

Primary DI Number: 04711200722291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658644174 *Terms of Use

Device Description: GlucoLeader Enhance Blood Glucose C4H vial packed test strip(BR/BMT)

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
62538	Glucose monitoring system IVD, point-of-care	A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. 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 [?]
K182428	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
Storage Environment Temperature: between 2 and 30 Degrees Celsius
Storage Environment Temperature: between 35.6 and 86 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f5711638-bb88-4841-9b2b-e0f806f90c54
Public Version Date: May 19, 2020
Public Version Number: 1
DI Record Publish Date: May 11, 2020