FDA.report

Home Health Kit

Primary DI
00843997016551
Brand
Home Health Kit
Company
MASIMO CORPORATION
Model
99042
Device description
Home Health Kit
Published
2024-09-09
Public version status
New
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

Product Codes

CodeName
DQAOximeter

Product Code Classifications

CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions

SubmissionSupplement
K181956000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K181956000Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation2019-01-23DQA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00843997016551PrimaryGS10

GMDN Terms

TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

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
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00843997019019Patient SafetyNet Lite950972026-02-23
00843997011006Radius VSM48422026-02-23
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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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