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
04035479110048Reocor S3655283655282014-08-13
04035479110055Reocor D3655293655292014-08-13
04035479114336Reocor D Redeladapter3712623712622014-08-21
04035479114343Reocor S Redeladapter3712633712632014-08-21
04035479114510Renamic PGH3715883715882014-08-21
04035479114527Renamic PGH ICD3715893715892014-08-21
04035479115142Renamic3719603719602014-08-12
04035479126391Renamic PSA Module3866103866102014-08-15
04035479143848Home Monitoring Service Center3.274053312014-08-21
04035479144241Home Monitoring Service Center3.284055522014-09-19
04035479144791BS IS-13308343308342014-08-04
04035479144807DH3316683316682014-08-14
04035479144968S 45-K1135881135882014-08-14
04035479144975S 45-S1300111300112014-08-14
04035479145019S 53-K1072351072352014-08-14
04035479145026S 53-S1300131300132014-08-14
04035479145033S 58-K1188771188772014-08-21
04035479148836Home Monitoring Service Center3.304084082015-04-22
04035479148850Home Monitoring Service Center3.324084102015-10-20
04035479152406Home Monitoring Service Center3.344193212016-04-18

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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
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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