FDA.reportPublic FDA data

Bloom2

Primary DI
00863019000351
Brand
Bloom2
Company
Fischer Medical
Model
Bloom2 Console
Catalog number
370050G
Device description
Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator
Published
2019-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173439000Bloom2 Programmable Electrophysiology StimulatorFischer Medical2018-03-29JOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863019000351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863019000351008630190003518630190003510863019000351

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology stimulation systemAn assembly of devices programmed to deliver precisely timed electrical impulses to the heart, during spontaneous and paced rhythms, for diagnostic cardiac stimulation. It typically includes electrodes/leads applied to the heart and an external pulse generator (EPG). It may be used in asynchronous or synchronous mode, to deliver stimuli of variable strength, and for pacing in a wide range of cycle lengths (typically from 150 to 1500 ms). It is used for performing physiologic cardiac tests such as to determine the function of various components of the atrioventricular conduction, factors required for induction and termination of tachycardia, and to assess sinus node function.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079978232
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863019000368Bloom2Bloom2 Console370344G2021-02-23
00863019000337Bloom2Bloom2 Stimulator370046G2019-01-25
00863019000344Bloom2Bloom2 Floater370049G2019-01-25
00863019000306Bloom206276G2016-09-12
00863019000313Bloom106459G2016-09-12
00863019000320Bloom108419G-22016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05414734219136EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067002709EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067007865EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067007872EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067007889EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067051820EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067051837EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
00863019000368Bloom2Fischer MedicalJOQ2021-02-23
00863019000337Bloom2Fischer MedicalJOQ2019-01-25
00863019000344Bloom2Fischer MedicalJOQ2019-01-25
05414734030236EP-4™ST. JUDE MEDICAL, INC.JOQ2018-12-14
05415067018069WorkMate Claris™ST. JUDE MEDICAL, INC.JOQ2018-11-09
05415067018076WorkMate Claris™ST. JUDE MEDICAL, INC.JOQ2018-11-09
09349714004739ORLABMICROPACE PTY LIMITEDJOQ2016-09-23
00863019000306BloomFischer MedicalJOQ2016-09-12
00863019000313BloomFischer MedicalJOQ2016-09-12
00863019000320BloomFischer MedicalJOQ2016-09-12
09349714004623MicropaceMICROPACE PTY LIMITEDJOQ2016-07-01
09349714004630StimLab MICROPACE PTY LIMITEDJOQ2016-07-01
09349714004708MicropaceMICROPACE PTY LIMITEDJOQ2016-07-01
05414734219112EP-4™ST. JUDE MEDICAL, INC.JOQ2016-04-22
05414734208741EP-4™ST. JUDE MEDICAL, INC.JOQ2016-04-15
05414734208758EP-4™ST. JUDE MEDICAL, INC.JOQ2016-04-15