AccessGUDID - DEVICE: Conifer Connect Diabetes (B552202153OTC0)

GUDID

Device Identifier (DI) Information

Brand Name: Conifer Connect Diabetes
Version or Model: v1.X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WELLDOC, INC.

Primary DI Number: B552202153OTC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021217115 *Terms of Use

Device Description: Conifer Connect includes Conifer Connect Diabetes and Conifer Connect Diabetes Rx, which is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. Conifer Connect Diabetes and Conifer Connect Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. Conifer Connect Diabetes Rx requires a prescription.

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):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61215	Home pharmaceutical management support software	A software package intended to be used by patients at home, and healthcare professionals in a clinical setting, to facilitate therapeutic pharmaceutical management decisions (e.g., dosage) by providing suggested regimes for individual patients based on their physical and laboratory data. It is intended to be used on a non-medical computerized device (e.g., to be used on mobile devices at point-of-care); it is not intended to support anaesthesia administration.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDC	Calculator, Drug Dose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203434	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
No Device Sizes

Device Record Status

Public Device Record Key: daa2c69d-66ef-4f2f-ae02-bcf74fcc1007
Public Version Date: September 05, 2024
Public Version Number: 1
DI Record Publish Date: August 28, 2024