Primary Device ID | 00843997014786 |
NIH Device Record Key | 70a9a468-f283-446a-9706-98b2ad34f5d0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Radius PPG |
Version Model Number | 9955 |
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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | true |
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 |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843997014786 [Primary] |
DQA | Oximeter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-07-24 |
Device Publish Date | 2020-07-16 |
00843997014786 | Radius PPG Kit, Neo Tetherless Pulse Oximetry Kit |
00843997014779 | Radius PPG Kit, Adt Tetherless Pulse Oximetry Kit |
00843997016155 | Radius PPG & Radius T for Masimo SafetyNet Kit |
00843997014861 | Radius PPG Wireless Receiver R25 |
00843997003032 | Radius PPG Pdt Adhesive Sensor |
00843997002950 | Radius PPG Pdt Adhesive Sensor |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() RADIUS PPG 88681221 not registered Live/Pending |
MASIMO CORPORATION 2019-11-05 |