FDA.reportPublic FDA data

Vista Gateway

Primary DI
04048675558576
Brand
Vista Gateway
Company
Shanghai Draeger Medical Instrument Co.,Ltd.
Model
2603248
Device description
Vista Gateway 128 Beds
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
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675558576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675558576040486755585764048675558576

GMDN Terms#

Term, Definition table
TermDefinition
Bedside information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the provision and utilization of administrative and clinical information at the patient's bedside. It is typically supplied for installation into a dedicated information system used at the patient's bedside or existing mainframe or decentralized computers/networks.

Regulatory Flags#

DUNS number
654469063
Device count
1
DM exempt
false
Premarket exempt
true
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
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
04048675596752IBP transducer adapter cable26012312025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONOUG2026-08-25
00850015699160Canary Flight PlanCanary Medical USA LLCOUG2026-08-07
00850015699177Canary Recovery CurveCanary Medical USA LLCOUG2026-08-07
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2025-11-17
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
00763000191887N/AMEDTRONIC, INC.OUG2025-09-05
00763000292102N/AMEDTRONIC, INC.OUG2025-09-05
00841492105671ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105688ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105695ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105701ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105718ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105725ResponderRAULAND-BORG CORPORATIONOUG2025-06-24