FDA.reportPublic FDA data

RFP-100A Connector Cable

Primary DI
00685447000938
Brand
RFP-100A Connector Cable
Company
Baylis Médicale Cie Inc
Model
RFX-BAY-OTW-12-SU
Published
2016-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023334000BMC CATHETER CONNECTOR CABLE, MODEL RFP-101Baylis Medical Co., Inc.2002-12-31DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00685447000938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447000938006854470009386854470009380685447000938

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA 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. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Feet

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5144889801info@baylismedical.com

Regulatory Flags#

DUNS number
249225954
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447018841VersaCross Connect Transseptal DilatorVXA12-84-35-PS-D1NA2023-08-15
00685447010487VersaCross Connect Transseptal Dilator VXA12-85-35-WM-D02022-05-19
00685447010531VersaCross Connect Transseptal DilatorVXA12-85-35-WM-D1NA2022-05-19
00685447005247VersaCross Large Access Transseptal DilatorVLA125-35-67-D0NA2021-06-10
00685447005254VersaCross Large Access Transseptal DilatorVLA125-35-67-D1NA2021-06-10
00685447005261VersaCross Large Access Transseptal DilatorVLA125-35-85-D0NA2021-06-10
00685447005278VersaCross Large Access Transseptal DilatorVLA125-35-85-D1NA2021-06-10
00685447005735VersaCross Steerable SheathVST85-35-BD-71L-D0NA2021-04-08
00685447005759VersaCross Steerable SheathVST85-35-BD-71M-D0NA2021-04-08
00685447005766VersaCross Steerable SheathVST85-35-BD-71M-D1NA2021-04-08
00685447005780VersaCross Steerable SheathVST85-35-BD-71S-D1NA2021-04-08
00685447003380VersaCross Transseptal SheathVXS85-35-63-45-D02019-06-26
00685447003397VersaCross Transseptal SheathVXS85-35-63-55-D02019-06-26
00685447003281VersaCross RF WireVXW-35-180-J2019-05-01
00685447003298VersaCross RF WireVXW-35-180-P2019-05-01
00685447003304VersaCross RF WireVXW-35-230-J2019-05-01
00685447003311VersaCross RF WireVXW-35-230-P2019-05-01
00685447001027Adult Dispersive ElectrodeRFA-GP-BAY2017-02-03
00685447011774VersaCross Access SolutionVXSK0026NA2022-07-08
00685447010272VersaCross Steerable Access SolutionVSTK00372022-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719689142209QMAPP Fysicon B.V.DSA2026-05-19
08719689142216QMAPP Fysicon B.V.DSA2026-05-19
08719689142223QMAPP Fysicon B.V.DSA2026-05-19
08719689142247QMAPP Fysicon B.V.DSA2026-05-19
08719689142254QMAPP Fysicon B.V.DSA2026-05-19
08719689142261QMAPP Fysicon B.V.DSA2026-05-19
08719689142322QMAPPFysicon B.V.DSA2026-05-19
08719689142339QMAPPFysicon B.V.DSA2026-05-19
08719689142346QMAPPFysicon B.V.DSA2026-05-19
08719689142353QMAPPFysicon B.V.DSA2026-05-19
08719689142360QMAPPFysicon B.V.DSA2026-05-19
08719689142377QMAPPFysicon B.V.DSA2026-05-19
08719689142384QMAPPFysicon B.V.DSA2026-05-19
08719689142391QMAPPFysicon B.V.DSA2026-05-19
08719689142407QMAPPFysicon B.V.DSA2026-05-19
08719689142414QMAPPFysicon B.V.DSA2026-05-19
08719689142469QMAPPFysicon B.V.DSA2026-05-19
08719689142476QMAPPFysicon B.V.DSA2026-05-19
08719689142483QMAPPFysicon B.V.DSA2026-05-19
08719689142490QMAPPFysicon B.V.DSA2026-05-19
08719689142506QMAPPFysicon B.V.DSA2026-05-19
08719689142513QMAPPFysicon B.V.DSA2026-05-19
08719689142520QMAPPFysicon B.V.DSA2026-05-19
08719689142537QMAPPFysicon B.V.DSA2026-05-19
08719689142544QMAPPFysicon B.V.DSA2026-05-19
08719689142551QMAPPFysicon B.V.DSA2026-05-19
08719689142568QMAPPFysicon B.V.DSA2026-05-19
08719689142575QMAPPFysicon B.V.DSA2026-05-19
08719689142582QMAPPFysicon B.V.DSA2026-05-19
08719689142599QMAPP Fysicon B.V.DSA2026-05-19