AccessGUDID - DEVICE: D-Care (00370914006017)

GUDID

Device Identifier (DI) Information

Brand Name: D-Care
Version or Model: 50002A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HUDSON SCIENTIFIC, LLC

Primary DI Number: 00370914006017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080339637 *Terms of Use

Device Description: DM2- kit contains one 60ct. bottle of Metformin 500mg and one 50ct. bottle Test Strips

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
60740	Home-use blood glucose spot-check system	An electrically-powered, portable device assembly intended to spot-check (user-initiated) measure and display blood glucose concentration in a patient with diabetes mellitus; it is not intended for continuous measurements (i.e., not a monitor). It includes a quantitative glucose meter that uses a blood specimen for the personal calibration of a noninvasive qualitative measurement device (e.g., near-infrared spectroscopy) which performs the measurements, typically on a finger, without blood draw; it also includes test strips, lancets, control solutions, and associated materials. It is designed to be used by a layperson in the home, and some types may in addition be used at the point-of-care.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)
CGA	Glucose Oxidase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132086	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 41 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 242eea32-ccb8-4722-bc43-2e3c3d7461d6
Public Version Date: September 09, 2020
Public Version Number: 9
DI Record Publish Date: July 24, 2017