AccessGUDID - DEVICE: HeartsCare C1 Plus Multi-Functional Monitoring System (00850014861056)

GUDID

Device Identifier (DI) Information

Brand Name: HeartsCare C1 Plus Multi-Functional Monitoring System
Version or Model: TD-4289
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hearts Bio, Inc.

Primary DI Number: 00850014861056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085509873 *Terms of Use

Device Description: No description.

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):	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?
56675	Multiple clinical chemistry analyser IVD, home-use	An electrically-powered instrument intended to be used by a layperson in the home or similar environment for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen; it does not include test reagents or disposable items. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter
CHH	Enzymatic Esterase--Oxidase, Cholesterol
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 887fcdf4-4416-4156-a9f7-6153fbd111bd
Public Version Date: April 08, 2025
Public Version Number: 1
DI Record Publish Date: March 31, 2025