FDA.report

iSpO2, Small, Consumer, Lightning

Primary DI
00843997008310
Brand
iSpO2, Small, Consumer, Lightning
Company
MASIMO CORPORATION
Model
9574
Published
2017-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OCHoximeter, infrared, sporting, aviation

Product Code Classifications

CodeDeviceSpecialtyClass
OCHOximeter, Infrared, Sporting, AviationCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00843997008310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843997008310008439970083108439970083100843997008310

GMDN Terms

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.

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
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
true
Sterilization required before use
false

Other Devices From This Company

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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

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