FDA.reportPublic FDA data

IBP transducer adapter cable

Primary DI
04048675597025
Brand
IBP transducer adapter cable
Company
Shanghai Draeger Medical Instrument Co.,Ltd.
Model
2601228
Device description
IBP transducer adapter cable, Utah Medical, 0.3m
Published
2025-12-16
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

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
K251669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251669000IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapterShanghai Draeger Medical Instrument Co., Ltd.2025-09-30DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675597025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675597025040486755970254048675597025

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

Regulatory Flags#

DUNS number
654469063
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048675558552Vista Gateway26032462026-07-13
04048675558569Vista Gateway26032472026-07-13
04048675558576Vista Gateway26032482026-07-13
04048675663997Vista Gateway26016682026-07-13
04048675723639Vista 30026010642026-07-13
04048675723646Vista 30026010652026-07-13
04048675723677Vista 300 Sidestream CO2 Module26010682026-07-13
04048675729631ECG trunk cable 12-lead SinglePin Vista30026019632026-07-13
04048675729655Adapter cable Masimo/ Nellcor SpO2 Vista 30026010082026-07-13
04048675746768Temp adapter Jack Vista 30026008852026-07-13
04048675785477Vista CMS26023252026-07-13
04048675785484Vista CMS26023332026-07-13
04048675785491Vista CMS26023342026-07-13
04048675785910Masimo SpO2 Module for Vista 300/S26100442026-07-13
04048675786108Vista CMS26023352026-07-13
04048675797173Vista 300 S26024252026-07-13
04048675797180Vista 300 S26024262026-07-13
04048675797197Vista 300 S26024272026-07-13
04048675596646IBP transducer adapter cable26012352025-12-16
04048675596660IBP transducer adapter cable26012342025-12-16

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