FDA.reportPublic FDA data

Gateway Software Server VF9.0

Primary DI
04049098099608
Brand
Gateway Software Server VF9.0
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
MS40048
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MSXSystem, Network And Communication, Physiological Monitors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203579000Infinity Gateway SuiteDraeger Medical Systems, Inc.2022-06-07MSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049098099608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049098099608040490980996084049098099608

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788289952
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048675786320Infinity M540MS406362026-10-26
04049098009751Infinity M540MS263722015-10-24
04049098009799IACS w/C700MS255202015-10-24
04049098054409IACS w/C500MS255102015-10-24
04049098054454SHP UNT INFINITY M540MS204012015-10-24
04049098095778SHIP UNIT M300+MS336482025-02-19
04049098053785Infinity etCO2 SmartPod57407202015-10-24
04049098061858Disposable Mechanical Ventilation CircuitMU047712025-12-10
04049098041829Disposable Mechanical Ventilation CircuitMU047712025-12-10
04049098000406Breathing hose for Resuscitaire with AutoBreath, disposable, 25 pcs.MU108412015-10-24
04048675673408Gateway Software Server VF9.0.1MS405452025-02-19
04048675762256Gateway Software Server VF9.1.137347182025-02-19
04048675777762Gateway Software Server VF9.1.237363762025-02-19
04048675780212Infinity R50-S RecorderMS412172025-02-19
04049098001519Infinity M300 Bedside ChargerMS295582025-02-19
04049098007061Infinity Gateway USB DongleMS117002025-02-19
04049098095730Infinity M300+MS339502025-02-19
04049098096423SHP EXC M300+MS336592025-02-19
04049098099264S/W SUB VF9.0 GatewayMS400462025-02-19
04049098001878Infinity CentralStation Wide (confi)MS268002015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944413835153Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.MSX2026-06-02
08720256776659Strap Silicon BlueCorsano Health B.V.MSX2026-06-02
08720256776987Charge Station 10 Sensors ACorsano Health B.V.MSX2026-06-02
00860006582012TigerConnect Alarm ManagementCritical AlertMSX2026-05-29
00884838107816Measurement Rack 6000Philips Medizin Systeme Böblingen GmbHMSX2026-05-19
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.MSX2026-03-18
B153301030AirStrip ONE Client WebAirstrip Technologies, Inc.MSX2026-03-18
B153500010AirStrip Alarm ManagementAirstrip Technologies, Inc.MSX2026-03-18
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00843997019019Patient SafetyNet LiteMASIMO CORPORATIONMSX2026-02-23
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyMSX2025-12-10
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00851725007399Central StationNihon Kohden Digital Health Solutions, LLCMSX2025-06-30
00853858006584EmpaticaEMPATICA SRLMSX2025-06-26
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
G2871002HUMAMedoPad Inc.MSX2025-04-28
00850064210262Sibel Spacelabs Trek TabletSibel Health Inc.MSX2025-04-02
00850064210163Central Hub CMSSibel Health Inc.MSX2025-03-27
00850064210194Central Hub SpeakerSibel Health Inc.MSX2025-03-27