Radius VSM

GUDID 00843997006996

Radius VSM Disposable NIBP Cuff, Adult, 20/box

MASIMO CORPORATION

Blood pressure cuff, single-use
Primary Device ID00843997006996
NIH Device Record Key348ff702-f80a-4b6a-a0b8-df29c28cf8fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadius VSM
Version Model Number4826
Company DUNS780421038
Company NameMASIMO CORPORATION
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100843997006996 [Unit of Use]
GS110843997006993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXQblood pressure cuff

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-27
Device Publish Date2024-08-19

On-Brand Devices [Radius VSM]

00843997007658Radius VSM Disposable NIBP Cuff, Large Adult, 20/box
00843997006996Radius VSM Disposable NIBP Cuff, Adult, 20/box
00843997006989Radius VSM Disposable NIBP Cuff, Small Adult, 20/box
00843997006187Radius VSM RAS-45 Acoustic Respiration Sensor, Adult, 10/Box
00843997009263Radius VSM Kit with NIBP
00843997010337Radius VSM Kit with Reusable Pod & NIBP
00843997009430Radius VSM NIBP Module, 1/Box
00843997009065Radius VSM Multi-functional Reusable Pod, 1/Box

Trademark Results [Radius VSM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RADIUS VSM
RADIUS VSM
88681229 not registered Live/Pending
MASIMO CORPORATION
2019-11-05

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