AccessGUDID - DEVICE: AngelMed Guardian EXD Model EXD-001 (00850012625025)

GUDID

Device Identifier (DI) Information

Brand Name: AngelMed Guardian EXD Model EXD-001
Version or Model: 0203-2100-002#P16
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0203-2100-002#P16
Company Name: Avertix Medical Inc.

Primary DI Number: 00850012625025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 171391779 *Terms of Use

Device Description: EXD-001 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:	No
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?
47805	Implantable cardiac monitor programmer/transmitter/alarm	A hand-held, electrically-powered device designed to be operated by a clinician or patient to non-invasively change the settings (e.g., turn on/off) of an implantable cardiac monitor (ICM), and/or extract data from the implant, and/or provide an alarm function; it is not intended to communicate with a therapeutic cardiac implant. It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. It may be used in the home or healthcare facility.	Active	false

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: 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: 20e2ceb5-10a6-4ce3-b7b1-7089f8a26c0e
Public Version Date: October 21, 2024
Public Version Number: 2
DI Record Publish Date: February 25, 2021