FDA.report

DuoMode Cable

Primary DI
00685447001102
Brand
DuoMode Cable
Company
Baylis Médicale Cie Inc
Model
RFX-BAY-DUO-100
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IKDCable, Electrode

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00685447001102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447001102006854470011026854470011020685447001102

GMDN Terms

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

Contacts

PhoneEmail
5144889801info@baylismedical.com

Regulatory Flags

DUNS number
249225954
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00685447019473VersaCross Connect™ LAAC Access SolutionVXAK0103VXAK01032025-02-25
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00685447019503VersaCross Connect™ LAAC Access SolutionVXAK0109VXAK01092025-02-25
00685447019558VersaCross™ Large Access SolutionVLAK0102VLAK01022025-02-25
00685447019565VersaCross™ Large Access SolutionVLAK0109VLAK01092025-02-25
00685447019572VersaCross™ Large Access SolutionVLAK0110VLAK01102025-02-25
00685447019589VersaCross™ Large Access SolutionVLAK0113VLAK01132025-02-25
00685447019596VersaCross™ Large Access SolutionVLAK0114VLAK01142025-02-25
00685447019602VersaCross™ Steerable Access SolutionVSTK0102VSTK01022025-02-25
00685447019619VersaCross™ Steerable Access SolutionVSTK0103VSTK01032025-02-25
00685447019626VersaCross™ Steerable Access SolutionVSTK0104VSTK01042025-02-25
00685447019633VersaCross™ Steerable Access SolutionVSTK0106VSTK01062025-02-25
00685447019640VersaCross™ Steerable Access SolutionVSTK0114VSTK01142025-02-25
00685447019657VersaCross™ Steerable Access SolutionVSTK0115VSTK01152025-02-25
00685447019664VersaCross™ Steerable Access SolutionVSTK0116VSTK01162025-02-25
00685447019671VersaCross™ Steerable Access SolutionVSTK0117VSTK01172025-02-25
00685447019688VersaCross™ Steerable Access SolutionVSTK0118VSTK01182025-02-25
00685447019695VersaCross™ Steerable Access SolutionVSTK0120VSTK01202025-02-25

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