FDA.reportPublic FDA data

5391

Primary DI
00643169382978
Brand
5391
Company
Oscor Inc.
Model
5391
Catalog number
5391
Device description
Single Chamber External Pacemaker
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K033130000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033130000PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOROsypka Medical, Inc.2003-10-31DTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169382978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169382978006431693829786431693829780643169382978

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 Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(727)937-2511sales@oscor.com

Regulatory Flags#

DUNS number
101835833
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813502010237Introducer Kit for Impella®0052-30140052-30142017-11-18
00813502010244Introducer Kit for Impella®0052-30150052-30152017-11-18
00813502010558Introducer Kit for Impella®0052-30210052-30212017-11-18
00813502010664Introducer Kit for Impella®0052-30250052-30252017-11-30
00813502011517Introducer Kit for Impella®0052-30010052-30012017-11-30
00813502011562Introducer Kit for Impella®0052-30000052-30002017-11-30
00813502011609Introducer Kit for Impella®0052-30060052-30062017-11-19
00885672013226VV-Plug667145-303VV-PLUG2026-06-01
00885672013233LV-1 Plug667147-303LV-1 PLUG2026-06-01
00885672013240IS4/DF4 Plug667148-303IS4/DF4 PLUG2026-06-01
00885672012892Volante™VLT-6.5-45-9-SVLT-6.5-45-9-S2026-05-08
00885672012908Volante™VLT-6.5-45-17-SVLT-6.5-45-17-S2026-05-08
00885672012915Volante™VLT-6.5-55-7-S-SDVLT-6.5-55-7-S-SD2026-05-08
00885672012922Volante™VLT-6.5-55-9-SVLT-6.5-55-9-S2026-05-08
00885672012939Volante™VLT-6.5-55-9-S-PFVLT-6.5-55-9-S-PF2026-05-08
00885672012946Volante™VLT-6.5-55-17-SVLT-6.5-55-17-S2026-05-08
00885672012953Volante™VLT-6.5-90-9-SVLT-6.5-90-9-S2026-05-08
00885672012960Volante™VLT-7-45-9-SVLT-7-45-9-S2026-05-08
00885672012977Volante™VLT-7-45-17-SVLT-7-45-17-S2026-05-08
00885672012984Volante™VLT-7-55-9-SVLT-7-55-9-S2026-05-08

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
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