AccessGUDID - DEVICE: AngelMed Guardian IMD Model AMSG3-E (00850012625001)

GUDID

Device Identifier (DI) Information

Brand Name: AngelMed Guardian IMD Model AMSG3-E
Version or Model: 0212-2100-001#P16
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0212-2100-001#P16
Company Name: Avertix Medical Inc.

Primary DI Number: 00850012625001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 171391779 *Terms of Use

Device Description: IMD AMSG3-E Kit

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:	Yes
Prescription Use (Rx):	No
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?
47804	Implantable cardiac monitor	A hermetically-sealed, electrically-powered device [an implantable cardiac monitor (ICM)] intended to be implanted to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias and/or acute coronary syndrome (ACS) changes; it may have a vibratory alarm function and the data can be telemetrically transmitted to an external device for alarming the patient and/or remote data transmission. It is used for a patient who experiences unexplained cardiac-related symptoms and/or is at risk for cardiac arrhythmias and/or ACS events.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QBI	Acute coronary syndrome event detector

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150009	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 97eddb46-2673-4d5a-a924-f945c231d2cf
Public Version Date: October 21, 2024
Public Version Number: 2
DI Record Publish Date: March 03, 2021