AccessGUDID - DEVICE: AngelMed Guardian Programmer Serial Cable, 6 Foot (00850012625087)

GUDID

Device Identifier (DI) Information

Brand Name: AngelMed Guardian Programmer Serial Cable, 6 Foot
Version or Model: 0204-2100-085#P10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0204-2100-085#P10
Company Name: Avertix Medical Inc.

Primary DI Number: 00850012625087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 171391779 *Terms of Use

Device Description: PROG-003 Serial Cable (6 foot)

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?
61680	Implantable cardiac device management application software	An application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers.	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: b4388d8a-7ff1-478a-9bb6-247a85c80122
Public Version Date: October 21, 2024
Public Version Number: 2
DI Record Publish Date: February 25, 2021