FDA.reportPublic FDA data

Bloom

Primary DI
00863019000320
Brand
Bloom
Company
Fischer Medical
Model
108419G-2
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JOQGenerator, Pulse, Pacemaker, External Programmable

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991293000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991293000EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATORFischer Medical Technologies, Inc.2000-05-05JOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863019000320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863019000320008630190003208630190003200863019000320

GMDN Terms#

Term, Definition table
TermDefinition
External pacemaker, epicardial pacingAn external pulse generator (EPG) designed to generate periodic electrical cardiac pacing impulses and transmits them to the heart via invasive (percutaneous) leads to stimulate the heart when the sino-atrial (SA) node is not functioning properly or when the heart has a conductive disorder. It is commonly used: 1) in an emergency; 2) during surgery; or 3) following open-heart surgery until the heart recovers. It is not intended for defibrillation or cardioversion. The leads (not included) are inserted into the heart through a major vein (e.g., subclavian) or attached directly to the heart wall.

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
00863019000351Bloom2Bloom2 Console370050G2019-01-25
00863019000306Bloom206276G2016-09-12
00863019000313Bloom106459G2016-09-12

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
00863019000351Bloom2Fischer 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
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