AccessGUDID - DEVICE: Advance Biometrix (B353AB12511)

GUDID

Device Identifier (DI) Information

Brand Name: Advance Biometrix
Version or Model: AB1251
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AB1251_US
Company Name: Lifesignals, Inc.

Primary DI Number: B353AB12511
Issuing Agency: HIBCC
Commercial Distribution End Date: August 26, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 798830720 *Terms of Use

Device Description: Wearable Biosensor - ECG Remote Monitoring Biosensor

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
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency
MWJ	Electrocardiograph, Ambulatory (Without Analysis)

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
Special Storage Condition, Specify: For long-term storage of more than 30 days, maintain between 10 and 27 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 45 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5f87bd0f-3962-44dc-9833-1d190729ab4e
Public Version Date: November 30, 2023
Public Version Number: 4
DI Record Publish Date: August 26, 2021