FDA.reportPublic FDA data

DF1-C6HV

Primary DI
04035479005221
Brand
DF1-C6HV
Company
BIOTRONIK SE & Co. KG
Model
118718
Catalog number
118718
Published
2014-08-25
Public version status
Update
Distribution status
Not 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
DTDpacemaker lead Adaptor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTDPacemaker Lead AdaptorCardiovascular2

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
04035479005221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479005221040354790052214035479005221

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead electrical adaptorAn implantable device designed to adapt the electrical connectors of an implanted pacemaker and/or defibrillator pacing lead to a non-compatible pacemaker or defibrillator (i.e., when they do not meet connection design). This device is implanted with the pacemaker or defibrillator system.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315620229
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479170295Tunneler L4578564578562026-05-28
04035479190538SW HMSC 3.664980924980922026-05-28
04035479182755Rivacor Sky DR-T4819824819822026-04-20
04035479182779Rivacor Sky VR-T DX4819834819832026-04-20
04035479182793Rivacor Sky VR-T4819844819842026-04-20
04035479182809Acticor Sky HF-T QP4819854819852026-04-20
04035479182816Acticor Sky HF-T4819864819862026-04-20
04035479182823Acticor Sky DR-T4819874819872026-04-20
04035479182830Acticor Sky VR-T DX4819884819882026-04-20
04035479182847Acticor Sky VR-T4819894819892026-04-20
04035479182854Rivacor Sky HF-T QP4819904819902026-04-20
04035479182861Rivacor Sky HF-T4819914819912026-04-20
04035479182984Rivacor Aura HF-T QP4820124820122026-04-20
04035479182991Rivacor Aura HF-T4820134820132026-04-20
04035479183004Rivacor Aura DR-T4820144820142026-04-20
04035479183011Rivacor Aura VR-T4820154820152026-04-20
04035479183028Rivacor Rise HF-T QP7820164820162026-04-20
04035479183035Rivacor Rise HF-T4820174820172026-04-20
04035479183042Rivacor Rise DR-T4820184820182026-04-20
04035479183059Rivacor Rise VR-T DX4820194820192026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000812041NAMEDTRONIC, INC.DTD2025-04-12
00885672011222Lead AdaptorOscor Inc.DTD2021-08-16
00763000059460NAMEDTRONIC, INC.DTD2019-05-11
10885672102453Lead AdaptorOscor Inc.DTD2017-11-27
00836559005544Lead AdaptorOscor Inc.DTD2017-11-27
00885672008352Lead AdaptorOscor Inc.DTD2017-11-27
00885672008369Lead AdaptorOscor Inc.DTD2017-11-27
00885672008260IS4/DF4 PlugOscor Inc.DTD2017-11-21
00802526497506Lead AdaptorOscor Inc.DTD2017-11-21
00802526497513Lead AdaptorOscor Inc.DTD2017-11-21
00802526497520Lead AdaptorOscor Inc.DTD2017-11-21
00802526497537Lead AdaptorOscor Inc.DTD2017-11-21
00802526505300LV-1 PlugOscor Inc.DTD2017-11-21
00802526540608VV-PlugOscor Inc.DTD2017-11-21
00885672008277Lead AdaptorOscor Inc.DTD2017-11-15
00885672008284Lead AdaptorOscor Inc.DTD2017-11-15
00885672008291VV-PlugOscor Inc.DTD2017-11-15
00885672008307VV-PlugOscor Inc.DTD2017-11-15
00885672008314LV-1 PlugOscor Inc.DTD2017-11-15
00885672008321Lead AdaptorOscor Inc.DTD2017-11-15
00885672008338Lead AdaptorOscor Inc.DTD2017-11-15
05414734506441SJM™ST. JUDE MEDICAL, INC.DTD2017-04-10
05414734506458SJM™ST. JUDE MEDICAL, INC.DTD2017-04-10
00836559004752BIS/BLV-13Oscor Inc.DTD2016-11-10
00836559006428Lead Adaptor Bipolar/UnipolarOscor Inc.DTD2016-02-25
00836559006411BLV/BIS-10Oscor Inc.DTD2015-12-29
00836559002611C/IS-10Oscor Inc.DTD2015-10-16
00836559002642M/IS-40Oscor Inc.DTD2015-10-16
00836559002666B/IS-15Oscor Inc.DTD2015-10-16
00836559002680BIS/IS-15Oscor Inc.DTD2015-10-16