FDA.reportPublic FDA data

Masimo SpO2 Module for Vista 300/S

Primary DI
04048675785910
Brand
Masimo SpO2 Module for Vista 300/S
Company
Shanghai Draeger Medical Instrument Co.,Ltd.
Model
2610044
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

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
04048675785910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675785910040486757859104048675785910

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, pulse oximetryA small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.

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
false
Serial number
true
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
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
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

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Primary DI, Brand, Company table
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