FDA.reportPublic FDA data

BS DF-1

Primary DI
04035479144784
Brand
BS DF-1
Company
BIOTRONIK SE & Co. KG
Model
119602
Catalog number
119602
Published
2014-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXYimplantable pacemaker Pulse-generator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXYImplantable Pacemaker Pulse-GeneratorCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980023000PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMBiotronik, Inc.1998-10-27LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479006051PackageGS110In Commercial Distribution
04035479144784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479006051040354790060514035479006051
04035479144784040354791447844035479144784

GMDN Terms#

Term, Definition table
TermDefinition
Implantable pulse generator port plugA non-active implantable device designed for insertion into the vacant/unused connector port of an implantable pulse generator (e.g., cardiac pacemaker/defibrillator, neurostimulator) to seal and electrically isolate the port, and to protect the parent device. It is typically made of metal and/or polymer materials; disposable devices intended to facilitate connection/stabilisation (e.g., torque wrench) may be included with the port plug.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit131 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags#

DUNS number
315620229
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479189235SW HMSC 3.654966314966312026-01-20
04035479162054Selectra 3D-40-324436244436242020-11-12
04035479162061Selectra 3D-40-394436254436252020-11-12
04035479162078Selectra 3D-55-324436264436262020-11-12
04035479162085Selectra 3D-55-394436274436272020-11-12
04035479162092Selectra 3D-65-324436284436282020-11-12
04035479162108Selectra 3D-65-394436294436292020-11-12
07640130455399Selectra3D-40-424517892020-11-12
07640130455405Selectra3D-55-424517902020-11-12
07640130455412Selectra3D-65-424517912020-11-12
04035479176228Selectra 3D-65-424517914517912021-06-02
04035479176235Selectra 3D-55-424517904517902021-06-02
04035479176242Selectra 3D-40-424517894517892021-06-02
04035479116828SelectraIC-50-653755452014-08-27
04035479116835SelectraIC-50-753755462014-08-27
04035479116842SelectraIC-90-653755472014-08-27
04035479116859SelectraIC-90-753755482014-08-27
04035479116651Selectra Amplatz 6.0-453755193755192014-08-27
04035479116668Selectra Amplatz 6.0-553755203755202014-08-27
04035479116675Selectra BIO2-453755233755232014-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067049575Merlin™ST. JUDE MEDICAL, INC.DXY2025-06-25
00763000812058NAMEDTRONIC, INC.DXY2025-04-12
05415067050045Neutrino™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.DXY2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.DXY2024-11-13
08031527018997BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019000BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019017BlueSkyMICROPORT CRM SRLDXY2023-06-23
08031527019024BlueSkyMICROPORT CRM SRLDXY2023-06-23
05415067040404NAST. JUDE MEDICAL, INC.DXY2023-01-09
05415067031174Merlin™ST. JUDE MEDICAL, INC.DXY2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.DXY2022-08-29
00763000181215NAMEDTRONIC, INC.DXY2021-05-14
00763000307660NAMEDTRONIC, INC.DXY2020-07-05
00763000059477NAMEDTRONIC, INC.DXY2018-12-28
05414734006880Identity™ST. JUDE MEDICAL, INC.DXY2017-02-06
05414734006811Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006835Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006842Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006866Integrity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006910Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734009553Victory™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734010474Verity™ST. JUDE MEDICAL, INC.DXY2017-02-03
05414734006828Identity™ST. JUDE MEDICAL, INC.DXY2017-01-25
05414734006903Identity™ST. JUDE MEDICAL, INC.DXY2017-01-25
00643169838604NAMEDTRONIC, INC.DXY2016-10-08