AccessGUDID - DEVICE: HEPRO.US - MM 1000 Test Strips Case (00850578007389)

GUDID

Device Identifier (DI) Information

Brand Name: HEPRO.US - MM 1000 Test Strips Case
Version or Model: Hepro.usTSC
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEPRO.US INC.

Primary DI Number: 00850578007389
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 21250
Labeler D-U-N-S® Number*: 080061451 *Terms of Use

Device Description: Case/Carton of 425 boxes of 50 TEST STRIPS HEPRO.US MM1000 - the FDA number is 3012098689 - the operator number is 10049962

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:	Yes
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
No Product Codes

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: 518a5675-29c1-4efe-a8d3-f5e1a47fd4aa
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 02, 2017