FDA.reportPublic FDA data

RD rainbow SET

Primary DI
00843997012522
Brand
RD rainbow SET
Company
MASIMO CORPORATION
Model
4278
Device description
RD rainbow SET RAM Dual Cable, R25-12
Published
2021-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZQMonitor, breathing frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843997012522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843997012522008439970125228439970125220843997012522

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyBZQ2026-04-15
20653405024962CONMEDConmed CorporationBZQ2026-03-24
10889483224366MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
10889483225295MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
00850064210309ANNE Chest Adhesive - Gentle Wear Shelf BoxSibel Health Inc.BZQ2025-12-17
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.BZQ2025-12-10
07640121881053103583 LuMon™ Contact Gel KitSenTec AGBZQ2025-09-08
10889483610565Resmed Sleep Apnealink CannulaSALTER LABSBZQ2025-07-11
00850064210200Sibel Spacelabs Trek Chest PatchSibel Health Inc.BZQ2025-04-02
00850064210224Sibel Spacelabs Trek ChargerSibel Health Inc.BZQ2025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch AdhesiveSibel Health Inc.BZQ2025-04-02
00850068747092Happy HealthHAPPY HEALTH, INC.BZQ2025-04-02
00850068747108Happy HealthHAPPY HEALTH, INC.BZQ2025-04-02
00850064210002ANNE Chest Sensor KitSibel Health Inc.BZQ2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.BZQ2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.BZQ2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.BZQ2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.BZQ2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.BZQ2025-03-26
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.BZQ2025-03-13
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDBZQ2025-03-05
G2331000000SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000010SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000020SansaTMHuxley Medical, Inc.BZQ2024-10-21
10843997006184Radius VSMMASIMO CORPORATIONBZQ2024-08-19
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZQ2024-06-19
00195278656681Portrait CVAXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278659446Portrait CSSXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278697165PORTRAIT HSWXBGE Healthcare Finland OyBZQ2024-04-30
00195278713193Portrait HUBXBGE Healthcare Finland OyBZQ2024-04-30