FDA.reportPublic FDA data

Rad-87® Vertical signal extraction pulse co-oximeter®

Primary DI
00843997005425
Brand
Rad-87® Vertical signal extraction pulse co-oximeter®
Company
MASIMO CORPORATION
Model
9228
Published
2017-09-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843997013611Direct MarkingGS10
00843997005425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843997013611008439970136118439970136110843997013611
00843997005425008439970054258439970054250843997005425

GMDN Terms#

Term, Definition table
TermDefinition
Pulse Co-oximeterA portable, battery-powered, electronic device designed to detect hypoxia (oxygen deficiency at the tissue level) via the transcutaneous multiwave measurement and display of carboxy-haemoglobin saturation (SpCO) and typically other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), and haemoglobin concentration (SpHb); pulse rate and haematocrit may also be calculated. A light-emitting diode (LED) and a receiving detector in a probe applied to a body site (e.g., a fingertip) are used to make multiwave measurements using spectrophotometry. The device is used in healthcare settings or the home, often to evaluate carbon monoxide poisoning.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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

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