Primary Device ID | 00843997014137 |
NIH Device Record Key | ef882ba8-f44c-4b37-bb14-87f5acac92da |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Radius-7 |
Version Model Number | 4547 |
Company DUNS | 780421038 |
Company Name | MASIMO CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843997014137 [Primary] |
GS1 | 00843997015875 [Direct Marking] |
MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-10-18 |
Device Publish Date | 2021-10-08 |
00843997012997 | with Wi-Fi |
00843997014274 | Radius-7 Conversion Kit |
00843997014267 | Radius-7 Wearable Pulse CO-Oximeter |
00843997014144 | Radius-7 with Wi-Fi Conversion Kit |
00843997014106 | Radius-7 Wearable Pulse CO-Oximeter with Wi-Fi |
00843997009249 | Radius-7 Wearable Pulse CO-Oximeter |
00843997014137 | Radius-7 Wearable Instrument |
00843997014120 | Radius-7 with Wi-Fi Wearable Instrument |
00843997010047 | Radius-7 Wearable Instrument |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RADIUS-7 85876396 4860118 Live/Registered |
Masimo Corporation 2013-03-14 |