AngelMed Guardian Programmer Application User's Manual CD 0204-2100-073#P16

GUDID 00850012625131

PROG-003 Application User's Manual CD

Angel Medical Systems, Inc.

Implantable cardiac device management application software
Primary Device ID00850012625131
NIH Device Record Key2715c78b-d856-4290-aba4-af73eeae506a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAngelMed Guardian Programmer Application User's Manual CD
Version Model Number0204-2100-073#P16
Catalog Number0204-2100-073#P16
Company DUNS171391779
Company NameAngel Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850012625131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QBIAcute coronary syndrome event detector

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-05
Device Publish Date2021-02-25