FDA.reportPublic FDA data

Adapter cable Masimo/ Nellcor SpO2 Vista 300

Primary DI
04048675729655
Brand
Adapter cable Masimo/ Nellcor SpO2 Vista 300
Company
Shanghai Draeger Medical Instrument Co.,Ltd.
Model
2601008
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K252250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252250000Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)Shanghai Draeger Medical Instrument Co., Ltd.2026-04-10MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675729655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675729655040486757296554048675729655

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.

Regulatory Flags#

DUNS number
654469063
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
04048675596752IBP transducer adapter cable26012312025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04048675746768Temp adapter Jack Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
06931973403939CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435398CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435404CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435411CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
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