Radius PPG
GUDID 00843997014786
Radius PPG Kit, Neo Tetherless Pulse Oximetry Kit
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 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| 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 |
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 |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843997014786 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183697
FDA Product Code
| DQA | Oximeter |
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 | 2020-07-24 |
| Device Publish Date | 2020-07-16 |
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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