FDA.reportPublic FDA data

CARDIOTRONIC

Primary DI
04260451441029
Brand
CARDIOTRONIC
Company
Osypka Medical GmbH
Model
PACE 203
Catalog number
2002
Device description
PACE 203 External Dual-Chamber Pacemaker (with clamping terminals)
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
K020896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020896000OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENEOsypka Medical, Inc.2002-06-14DTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260451441029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260451441029042604514410294260451441029

GMDN Terms#

Term, Definition table
TermDefinition
External pacemaker, epicardial pacingAn external pulse generator (EPG) designed to generate periodic electrical cardiac pacing impulses and transmits them to the heart via invasive (percutaneous) leads to stimulate the heart when the sino-atrial (SA) node is not functioning properly or when the heart has a conductive disorder. It is commonly used: 1) in an emergency; 2) during surgery; or 3) following open-heart surgery until the heart recovers. It is not intended for defibrillation or cardioversion. The leads (not included) are inserted into the heart through a major vein (e.g., subclavian) or attached directly to the heart wall.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 858 454 0600mail@cardiotronic.net

Regulatory Flags#

DUNS number
317157048
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260451441180Osypka MedicalAESCULON2026-04-24
04260451441043CARDIOTRONICICON2021-04-30
04260451441050CARDIOTRONIC PACE 10120042021-04-30
04260451441067CARDIOTRONIC PACE 20320032021-04-30
04260451441173Osypka MedicalPSA 2002021-04-30
04260451441012CARDIOTRONIC PACE 10120012016-09-13

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
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
04035479079581PK-83-B/2,5mBIOTRONIK SE & Co. KGDTE2014-08-19
04035479080228PK-83-B/1,5mBIOTRONIK SE & Co. KGDTE2014-08-19