FDA.reportPublic FDA data

Rad-8® Vertical signal extraction pulse oximeter

Primary DI
00843997006538
Brand
Rad-8® Vertical signal extraction pulse oximeter
Company
MASIMO CORPORATION
Model
9213
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00843997013581Direct MarkingGS10
00843997006538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843997013581008439970135818439970135810843997013581
00843997006538008439970065388439970065380843997006538

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10843997011003Radius VSM48422026-02-23
10843997016015Radius VSM46952026-02-23
00843997019163Radius VSM90372026-02-23
00843997019019Patient SafetyNet Lite950972026-02-23
00843997011006Radius VSM48422026-02-23
00843997016018Radius VSM46952026-02-23
00843997015530Rad-G YI Multisite Reusable Sensor46532021-10-08
10843997003381LNCS26902024-08-16
10843997003398LNCS26912024-08-16
10843997003404LNCS26922024-08-16
10843997003411LNCS26942024-08-16
10843997004968MasimoSET LNCS® E1™ SpO2 Adult Pulse Oximeter Adhesive Sensor291829182016-08-24
10843997010921RD rainbow SET-240282020-09-03
10843997010938RD rainbow SET-240292020-09-03
10843997013496O343842020-09-03
00843997010825rainbow SET418341832023-02-13
00843997010818rainbow SET41822022-11-21
10843997002797MasimoSET® LNCS® Adtx-3 SpO2 Adult Pulse Oximeter Adhesive Sensor260126012016-08-24
10843997002803MasimoSET® LNCS® Pdtx-3 SpO2 Pediatric Pulse Oximeter Adhesive Sensor260226022016-08-24
10843997002810MasimoSET® LNCS® Inf-3 SpO2 Infant Pulse Oximeter Adhesive Sensor260326032016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551028900069Cables and SensorsXINMED SDN. BHD.DQA2026-04-22
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320387MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320479MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320691MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19
08052990320707MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19
G096MNKS2NORAC30MEDALinkRising Eagle Medical LLCDQA2025-10-08
08052990321704MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-02-27
08052990320264MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990320271MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990322084MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990322213MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
10197344042647MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042678MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042692MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042715MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042739MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
07630002800754HAMILTON-T1Hamilton Medical AGDQA2024-08-21
10843997003343LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003381LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003398LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003404LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003411LNCSMASIMO CORPORATIONDQA2024-08-16
10843997010983RD SETMASIMO CORPORATIONDQA2024-08-16
10843997010990RD SETMASIMO CORPORATIONDQA2024-08-16
07640121880988103149 Calibration GasSenTec AGDQA2024-07-05
07640121880995103164 tCOM+SenTec AGDQA2024-07-05