PK-83-B/2,5m

Primary DI
04035479079581
Brand
PK-83-B/2,5m
Company
BIOTRONIK SE & Co. KG
Model
347485
Catalog number
347485
Published
2014-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479079581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479079581040354790795814035479079581

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 Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
04035479010355PK-67-L/2,6mBIOTRONIK SE & Co. KGDTE2014-08-20
04035479015473PK-67-S/0,8mBIOTRONIK SE & Co. KGDTE2014-08-20
04035479049300PK-175/2,3mBIOTRONIK SE & Co. KGDTE2014-08-19
04035479080228PK-83-B/1,5mBIOTRONIK SE & Co. KGDTE2014-08-19