AccessGUDID - DEVICE: Cardea SOLO (10857553006129)

GUDID

Device Identifier (DI) Information

Brand Name: Cardea SOLO
Version or Model: C300/D300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C300/D300
Company Name: CARDIAC INSIGHT, INC.

Primary DI Number: 10857553006129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827419834 *Terms of Use

Device Description: Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300).

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	Yes
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?
35162	Electrocardiographic ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	Computer, Diagnostic, Programmable
DSH	Recorder, Magnetic Tape, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162503	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: 9f6a63e5-7bc4-42b6-a8fc-ed193778648a
Public Version Date: November 08, 2019
Public Version Number: 5
DI Record Publish Date: July 31, 2017