FDA.report

MyView™ Presence Tag

Primary DI
00843997008259
Brand
MyView™ Presence Tag
Company
MASIMO CORPORATION
Model
3715
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MSXSYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS

Product Code Classifications

CodeDeviceSpecialtyClass
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00843997008259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843997008259008439970082598439970082590843997008259

GMDN Terms

TermDefinition
Pulse oximetry telemetric monitoring system transmitterA body-worn, battery-powered component of a pulse oximetry telemetric monitoring system designed to continuously measure and wirelessly transmit haemoglobin oxygen saturation (SpO2) signals to the system's receiver. The transmitter typically includes an antenna and attached sensors (e.g., lead wires and electrodes) that are connected to the patient. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(949)297-7498TechService-US@masimo.com

Regulatory Flags

DUNS number
780421038
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00843997019019Patient SafetyNet Lite950972026-02-23
00843997011006Radius VSM48422026-02-23
00843997016018Radius VSM46952026-02-23
00843997010825rainbow SET418341832023-02-13
10843997001448rainbow® R20 SpCO® SpO2 SpMet® Pediatric Pulse CO-Oximeter® Adhesive Sensor222222222016-08-23
10843997001455rainbow®R20L SpCO® SpO2 SpMet® Infant Pulse CO-Oximeter® Adhesive Sensor222022202016-08-23
10843997001462MasimoSET® rainbow R25 SpCO SpO2 SpMet® Adult Pulse CO-Oximeter® Adhesive Sensor222122212016-08-23
10843997001479rainbow R25-L SpCO SpO2 SpMet® Adult/Neonatal Pulse CO-Oximeter® Adhesive Sensor221922192016-08-23
10843997002322rainbow R1 25L SpHb SpO2 SpMet Adult/Neonatal Pulse CO-Oximeter Adhesive Sensor241424142016-08-24
10843997002339R1 25 SpHb® SpO2, SpMet® Adult Pulse Co-Oximeter® Adhesive Sensor37922016-08-25
10843997002346R1 20 Pediatric/Slender digit Pulse Co-Oximeter® Adhesive Sensor37932016-08-25
10843997002353rainbow® R1 20L SpHb® SpO2 SpMet® Infant CO-Oximeter® Adhesive Sensor241524152016-08-24
10843997003701rainbow ReSposable R2-20a Pediatric/Slender Digit Pulse CO-Oximeter Sensor27552017-10-06
10843997003725rainbow ReSposable, R2-25a, Adult Pulse CO-Oximeter Disposable Optical Sensor27532017-10-06
10843997004067MasimoSET® Rainbow Adult Sensor Sample Pack22912016-08-23
10843997004074MasimoSET® Rainbow Ped/Inf Sensor Sample Pack22922016-08-23
10843997007181R2-25r SpHb SpO2 SpMet Adult Pulse CO-Oximeter Reusable Optical Sensor (ROS)33952016-08-24
10843997007198R2-20r Pediatric/Slender digit Pulse CO-Oximeter Reusable Optical Sensor (ROS)34112016-08-24
10843997007389rainbow ReSposable Pulse CO-Oximeter Sensor System, Adult34572017-10-12
10843997007396rainbow ReSposable Pulse CO-Oximeter Sensor System, pediatric/slender digit34582017-10-12

Other Devices Sharing Product Codes

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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
00884838126381eCareManagerPhilips Medical Systems Nederland B.V.MSX2025-03-17
00860011811961MessengerSPOK INC.MSX2025-02-19
04048675673408Gateway Software Server VF9.0.1DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04048675762256Gateway Software Server VF9.1.1DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04048675777762Gateway Software Server VF9.1.2DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04049098007061Infinity Gateway USB DongleDRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04049098099264S/W SUB VF9.0 GatewayDRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04049098099608Gateway Software Server VF9.0DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
06936415911164TM80 Telemetry Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.MSX2025-01-24
00884838123175IntelliVue XDS SoftwarePhilips Medizin Systeme Böblingen GmbHMSX2024-12-11
00860011811947MessengerSPOK INC.MSX2024-10-18
00860011811954MessengerSPOK INC.MSX2024-10-18
06936415972417BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.MSX2024-09-24
10841522129216SpacelabsSPACELABS HEALTHCARE (WASHINGTON), INCMSX2024-08-16
00860011811930MessengerSPOK INC.MSX2024-07-30
00086001142550MessengerSPOK INC.MSX2024-07-30
00860011811923MessengerSPOK INC.MSX2024-07-30
00860011811909MessengerSPOK INC.MSX2024-03-14
00860011811916MessengerSPOK INC.MSX2024-03-14
05060526847706Current Health Wearable Monnitoring SystemCURRENT HEALTH LIMITEDMSX2024-02-01
04931921017159CNS-2101 Central MonitorNIHON KOHDEN CORPORATIONMSX2023-10-30
04931921017166CNS-2101 Central MonitorNIHON KOHDEN CORPORATIONMSX2023-10-01
00195278093998PORTRAIT HUB01GE Healthcare Finland OyMSX2023-09-01
00195278201980PORTRAIT AAB01GE Healthcare Finland OyMSX2023-09-01
00884838121249eCareManagerPhilips Medical Systems Nederland B.V.MSX2023-08-08