Radius PPG 4584
GUDID 00843997003032
Radius PPG Pdt Adhesive Sensor
MASIMO CORPORATION
Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter Pulse Co-oximeter probe, single-use Pulse Co-oximeter probe, single-use Pulse Co-oximeter probe, single-use Pulse Co-oximeter probe, single-use Pulse Co-oximeter probe, single-use Pulse Co-oximeter probe, single-use Pulse Co-oximeter probe, single-use Pulse Co-oximeter probe, single-use Pulse Co-oximeter probe, single-use Pulse Co-oximeter probe, single-use Pulse Co-oximeter probe, single-use Pulse Co-oximeter probe, single-use| Primary Device ID | 00843997003032 |
| NIH Device Record Key | cb7d2aa4-8c14-4cf4-b171-afc04b14e04b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Radius PPG |
| Version Model Number | 4584 |
| Catalog Number | 4584 |
| Company DUNS | 780421038 |
| Company Name | MASIMO CORPORATION |
| Device Count | 20 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843997003032 [Unit of Use] |
| GS1 | 10843997003039 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183697
FDA Product Code
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-30 |
| Device Publish Date | 2023-08-22 |
On-Brand Devices [Radius PPG]
| 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 |
Trademark Results [Radius PPG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RADIUS PPG 88681221 not registered Live/Pending |
MASIMO CORPORATION 2019-11-05 |
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