FDA.reportPublic FDA data

PK-67-L/2,6m

Primary DI
04035479010355
Brand
PK-67-L/2,6m
Company
BIOTRONIK SE & Co. KG
Model
123672
Catalog number
123672
Published
2014-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTEPULSE-GENERATOR, PACEMAKER, EXTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTEPulse-Generator, Pacemaker, ExternalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964190000ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERBiotronik, Inc.1997-07-10DTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479010355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479010355040354790103554035479010355

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
00850056280020SoloPace EPGSOLO PACE INC.DTE2026-02-02
00850056280013Solo Pace Control SystemSOLO PACE INC.DTE2025-01-23
00850056280037Solo Pace Control SystemSOLO PACE INC.DTE2025-01-23
04260451441050CARDIOTRONIC Osypka Medical GmbHDTE2021-04-30
04260451441067CARDIOTRONIC Osypka Medical GmbHDTE2021-04-30
04260451441173Osypka MedicalOsypka Medical GmbHDTE2021-04-30
00763000162443NAMEDTRONIC, INC.DTE2018-11-11
00643169723160NAMEDTRONIC, INC.DTE2017-03-12
00643169725126NAMEDTRONIC, INC.DTE2017-01-29
00847946021986HWD Electrode SetZoll Medical CorporationDTE2016-10-20
00885672005467PACE 203HOscor Inc.DTE2016-09-17
04260451441012CARDIOTRONIC Osypka Medical GmbHDTE2016-09-13
04260451441029CARDIOTRONIC Osypka Medical GmbHDTE2016-09-13
00836559008859PACE 101HOscor Inc.DTE2016-09-09
00836559008866PACE 203HOscor Inc.DTE2016-09-09
006431693829785391Oscor Inc.DTE2016-09-09
00847946021191PRO PADZZoll Medical CorporationDTE2016-08-03
00847946016661PRO PADZZoll Medical CorporationDTE2015-10-21
00643169508767NAMEDTRONIC, INC.DTE2014-11-13
00847946016401PRO PADZZoll Medical CorporationDTE2014-09-24
00847946016463PRO PADZZoll Medical CorporationDTE2014-09-24
00643169230859NAMEDTRONIC, INC.DTE2014-09-23
00643169305120NAMEDTRONIC, INC.DTE2014-09-23
04035479015473PK-67-S/0,8mBIOTRONIK SE & Co. KGDTE2014-08-20
04035479049300PK-175/2,3mBIOTRONIK SE & Co. KGDTE2014-08-19
04035479079581PK-83-B/2,5mBIOTRONIK SE & Co. KGDTE2014-08-19
04035479080228PK-83-B/1,5mBIOTRONIK SE & Co. KGDTE2014-08-19