FDA.reportPublic FDA data

NA

Primary DI
00802526580208
Brand
NA
Company
BOSTON SCIENTIFIC CORPORATION
Model
6763
Device description
PSA Cable
Published
2017-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DTCANALYZER, PACEMAKER GENERATOR FUNCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTCAnalyzer, Pacemaker Generator FunctionCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526580208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526580208008025265802088025265802080802526580208

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.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
106295384
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14
08714729880318Rhythmia™ Mapping SystemM004RBLMR1002016-09-24
08714729938736RHYTHMIA HDx™M004RH20010M004RH200102017-05-03
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B33596020000External Pacemaker AnalyzerNETECH CORPORATIONDTC2024-08-23
B3359600External Pacemaker AnalyzerNETECH CORPORATIONDTC2023-07-03
00763000688400CareLink SmartSync™MEDTRONIC, INC.DTC2022-10-28
04035479092443PK-141/2.8mBIOTRONIK SE & Co. KGDTC2021-05-06
00763000201289CareLink SmartSync™MEDTRONIC, INC.DTC2019-06-01
00763000002039CareLink SmartSync™ Azure Astra ApplicationMEDTRONIC, INC.DTC2019-04-06
00643169957657CareLink SmartSync™MEDTRONIC, INC.DTC2019-03-30
00850540007157SigmaPace 1000FLUKE ELECTRONICS CORPORATIONDTC2018-05-24
B3359500External Pacemaker AnanlyzerNETECH CORPORATIONDTC2017-06-16
00643169833715CareLink SmartSync™ Common ApplicationMEDTRONIC, INC.DTC2017-05-25
00643169833739CareLink SmartSync™ Common ApplicationMEDTRONIC, INC.DTC2017-05-25
00643169833753CareLink SmartSync™ PSA ApplicationMEDTRONIC, INC.DTC2017-05-25
00643169868540CareLink SmartSync™MEDTRONIC, INC.DTC2017-05-25