FDA.reportPublic FDA data

PK-67-S/0,8m

Primary DI
04035479015473
Brand
PK-67-S/0,8m
Company
BIOTRONIK SE & Co. KG
Model
128085
Catalog number
128085
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
04035479015473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479015473040354790154734035479015473

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
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
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
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