FDA.reportPublic FDA data

Infinity M300 PWT

Primary DI
04049098050104
Brand
Infinity M300 PWT
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
MS18623
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130711000INFINITY CENTRALSTATION WITH INFINITY M300Draeger Medical Systems, Inc.2013-04-11MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049098050104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049098050104040490980501044049098050104

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004372437info@draeger.com

Regulatory Flags#

DUNS number
788289952
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04049098099608Gateway Software Server VF9.0MS400482025-02-19
04049098001878Infinity CentralStation Wide (confi)MS268002015-10-24
04049098000185Resuscitaire Birthing Room Warmer (WBR82)MU205122015-10-24
04049098000192TI500 Globetrotter Neonatal Transport SystemMU205082015-10-24
04049098000215Resuscitaire Radiant Warmer (RW82, RW82 VHA)MU205032015-10-24
04049098000413Restraint strap, replacement, carton of 10MU060112015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838119017Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119024Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119031Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119062Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119185Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119192Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B353UB25501UbiqVue MultiparameterLifesignals, Inc.MHX2024-11-29
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMHX2024-06-07
B353UA2550BG1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550C1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550MR1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550RB1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550S1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550R1UbiqVue Lifesignals, Inc.MHX2024-05-06
B353UB15501UbiqVue MultiparameterLifesignals, Inc.MHX2024-05-06
00382830062947Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062954Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyMHX2023-04-19