FDA.reportPublic FDA data

AngelMed Guardian EXD Model EXD-001 Battery, 30 Pack

Primary DI
20850012625159
Brand
AngelMed Guardian EXD Model EXD-001 Battery, 30 Pack
Company
Avertix Medical Inc.
Model
0203-2100-010
Catalog number
0203-2100-010
Device description
EXD-001 Battery, 30 Pack
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
20850012625159PrimaryGS10
00850012625155Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085001262515920850012625159
00850012625155008500126251558500126251550850012625155

GMDN Terms#

Term, Definition table
TermDefinition
Primary battery"A non-rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The device includes terminals and may include a case. The size, shape, and chemical composition of the device should be specified according to the requirements in ""IEC 60086-1 Primary batteries - Part 1: General"", or the latest version of this standard."

Regulatory Flags#

DUNS number
171391779
Device count
30
Expiration 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
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
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
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