FDA.reportPublic FDA data

Guardian Programmer Model PROG-004

Primary DI
00850012625162
Brand
Guardian Programmer Model PROG-004
Company
Avertix Medical Inc.
Model
0217-2100-004#P18
Catalog number
0217-2100-004#P18
Device description
PROG-004 Kit (US)
Published
2025-03-05
Public version status
New
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
P150009012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150009012Guardian SystemAvertix Medical, Inc.2018-04-09QBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012625162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012625162008500126251628500126251620850012625162

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cardiac device management application softwareAn 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.

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
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
00850012625032AngelMed Guardian EXD Model EXD-0010203-2100-002-C4#P160203-2100-002-C4#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
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
00850012625032AngelMed 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