FDA.reportPublic FDA data

AngelMed Guardian EXD Model EXD-001

Primary DI
00850012625032
Brand
AngelMed Guardian EXD Model EXD-001
Company
Avertix Medical Inc.
Model
0203-2100-002-C4#P16
Catalog number
0203-2100-002-C4#P16
Device description
EXD-001 Kit (Latin-American Spanish)
Published
2021-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QBIAcute coronary syndrome event detector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBIAcute Coronary Syndrome Event DetectorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150009000Guardian SystemAvertix Medical, Inc.2018-04-09QBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012625032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012625032008500126250328500126250320850012625032

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cardiac monitor programmer/transmitter/alarmA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
171391779
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012625162Guardian Programmer Model PROG-0040217-2100-004#P180217-2100-004#P182025-03-05
10850012625152AngelMed Guardian EXD Model EXD-001 Battery, 10 Pack0203-2100-0130203-2100-0132021-02-25
20850012625159AngelMed Guardian EXD Model EXD-001 Battery, 30 Pack0203-2100-0100203-2100-0102021-02-25
00850012625001AngelMed Guardian IMD Model AMSG3-E0212-2100-001#P160212-2100-001#P162021-03-03
00850012625018AngelMed Guardian Torque Wrench2100-0012100-0012021-02-25
00850012625025AngelMed Guardian EXD Model EXD-0010203-2100-002#P160203-2100-002#P162021-02-25
00850012625049AngelMed Guardian EXD Carrying Case0203-2100-0040203-2100-0042021-02-25
00850012625056AngelMed Guardian EXD Lanyard0203-2100-0030203-2100-0032021-02-25
00850012625063AngelMed Guardian Programmer Model PROG-0030204-2100-075#P160204-2100-075#P162021-02-25
00850012625070AngelMed Guardian Programmer Wand EXD Model EXD-0010204-2100-067#P150204-2100-067#P152021-02-25
00850012625087AngelMed Guardian Programmer Serial Cable, 6 Foot0204-2100-085#P100204-2100-085#P102021-02-25
00850012625094AngelMed Guardian Programmer Serial Cable, 10 Foot0204-2100-1120204-2100-1122021-02-25
00850012625100AngelMed Guardian Programmer External Power Accessories0204-2100-093#P100204-2100-093#P102021-02-25
00850012625124AngelMed Guardian Programmer USB Flash Drive0204-2100-077#P100204-2100-077#P102021-02-25
00850012625131AngelMed Guardian Programmer Application User's Manual CD0204-2100-073#P160204-2100-073#P162021-02-25
00850012625148AngelMed Guardian Programmer PROG-003 Carrying Case0204-2100-079#P100204-2100-079#P102021-02-25
00850012625155AngelMed Guardian EXD Model EXD-001 Battery0203-2100-0060203-2100-0062021-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850012625162Guardian Programmer Model PROG-004Avertix Medical Inc.QBI2025-03-05
00850012625155AngelMed Guardian EXD Model EXD-001 BatteryAvertix Medical Inc.QBI2021-08-23
00850012625001AngelMed Guardian IMD Model AMSG3-EAvertix Medical Inc.QBI2021-03-03
10850012625152AngelMed Guardian EXD Model EXD-001 Battery, 10 PackAvertix Medical Inc.QBI2021-02-25
20850012625159AngelMed Guardian EXD Model EXD-001 Battery, 30 PackAvertix Medical Inc.QBI2021-02-25
00850012625018AngelMed Guardian Torque WrenchAvertix Medical Inc.QBI2021-02-25
00850012625025AngelMed Guardian EXD Model EXD-001Avertix Medical Inc.QBI2021-02-25
00850012625049AngelMed Guardian EXD Carrying CaseAvertix Medical Inc.QBI2021-02-25
00850012625056AngelMed Guardian EXD LanyardAvertix Medical Inc.QBI2021-02-25
00850012625063AngelMed Guardian Programmer Model PROG-003Avertix Medical Inc.QBI2021-02-25
00850012625070AngelMed Guardian Programmer Wand EXD Model EXD-001Avertix Medical Inc.QBI2021-02-25
00850012625087AngelMed Guardian Programmer Serial Cable, 6 FootAvertix Medical Inc.QBI2021-02-25
00850012625094AngelMed Guardian Programmer Serial Cable, 10 FootAvertix Medical Inc.QBI2021-02-25
00850012625100AngelMed Guardian Programmer External Power AccessoriesAvertix Medical Inc.QBI2021-02-25
00850012625124AngelMed Guardian Programmer USB Flash DriveAvertix Medical Inc.QBI2021-02-25
00850012625131AngelMed Guardian Programmer Application User's Manual CDAvertix Medical Inc.QBI2021-02-25
00850012625148AngelMed Guardian Programmer PROG-003 Carrying CaseAvertix Medical Inc.QBI2021-02-25