Home GUDID 04035479079581
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
Product Codes# Code, Name table Code Name DTE PULSE-GENERATOR, PACEMAKER, EXTERNAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DTE Pulse-Generator, Pacemaker, External Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04035479079581 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04035479079581 04035479079581 4035479079581
GMDN Terms# Term, Definition table Term Definition Electrical-only medical device connection cable, reusable A 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 Type Low High Condition Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850056280020 SoloPace EPG SOLO PACE INC. DTE 2026-02-02 00850056280013 Solo Pace Control System SOLO PACE INC. DTE 2025-01-23 00850056280037 Solo Pace Control System SOLO PACE INC. DTE 2025-01-23 04260451441050 CARDIOTRONIC Osypka Medical GmbH DTE 2021-04-30 04260451441067 CARDIOTRONIC Osypka Medical GmbH DTE 2021-04-30 04260451441173 Osypka Medical Osypka Medical GmbH DTE 2021-04-30 00763000162443 NA MEDTRONIC, INC. DTE 2018-11-11 00643169723160 NA MEDTRONIC, INC. DTE 2017-03-12 00643169725126 NA MEDTRONIC, INC. DTE 2017-01-29 00847946021986 HWD Electrode Set Zoll Medical Corporation DTE 2016-10-20 00885672005467 PACE 203H Oscor Inc. DTE 2016-09-17 04260451441012 CARDIOTRONIC Osypka Medical GmbH DTE 2016-09-13 04260451441029 CARDIOTRONIC Osypka Medical GmbH DTE 2016-09-13 00836559008859 PACE 101H Oscor Inc. DTE 2016-09-09 00836559008866 PACE 203H Oscor Inc. DTE 2016-09-09 00643169382978 5391 Oscor Inc. DTE 2016-09-09 00847946021191 PRO PADZ Zoll Medical Corporation DTE 2016-08-03 00847946016661 PRO PADZ Zoll Medical Corporation DTE 2015-10-21 00643169508767 NA MEDTRONIC, INC. DTE 2014-11-13 00847946016401 PRO PADZ Zoll Medical Corporation DTE 2014-09-24 00847946016463 PRO PADZ Zoll Medical Corporation DTE 2014-09-24 00643169230859 NA MEDTRONIC, INC. DTE 2014-09-23 00643169305120 NA MEDTRONIC, INC. DTE 2014-09-23 04035479010355 PK-67-L/2,6m BIOTRONIK SE & Co. KG DTE 2014-08-20 04035479015473 PK-67-S/0,8m BIOTRONIK SE & Co. KG DTE 2014-08-20 04035479049300 PK-175/2,3m BIOTRONIK SE & Co. KG DTE 2014-08-19 04035479080228 PK-83-B/1,5m BIOTRONIK SE & Co. KG DTE 2014-08-19