AccessGUDID - DEVICE: HEPRO.US MM1000 Blood Glucose Monitoring System Kit (00854427007148)

GUDID

Device Identifier (DI) Information

Brand Name: HEPRO.US MM1000 Blood Glucose Monitoring System Kit
Version or Model: KIT - Glucose Monitoring System
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEPRO.US INC.

Primary DI Number: 00854427007148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080061451 *Terms of Use

Device Description: Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lancets, 1 logbook, 1 user manual

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
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?
61913	Glucose/haematocrit 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 together for the quantitative measurement of glucose and haematocrit 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)
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: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 9c3aa190-e42c-4670-82d6-4317a4198256
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 20, 2017