Radius VSM
GUDID 00843997016018
Radius VSM ECG Electrode Set Adult 3-Lead Set
MASIMO CORPORATION
Electrocardiographic electrode, single-use| Primary Device ID | 00843997016018 |
| NIH Device Record Key | 00d18b0c-1a78-4fd5-bd89-80737e07988f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Radius VSM |
| Version Model Number | 4695 |
| 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 | 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 |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843997016018 [Unit of Use] |
| GS1 | 10843997016015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223498
FDA Product Code
| DPS | Electrocardiograph |
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 | 2026-03-03 |
| Device Publish Date | 2026-02-23 |
On-Brand Devices [Radius VSM]
| 00843997007658 | Radius VSM Disposable NIBP Cuff, Large Adult, 20/box |
| 00843997006996 | Radius VSM Disposable NIBP Cuff, Adult, 20/box |
| 00843997006989 | Radius VSM Disposable NIBP Cuff, Small Adult, 20/box |
| 00843997006187 | Radius VSM RAS-45 Acoustic Respiration Sensor, Adult, 10/Box |
| 00843997009263 | Radius VSM Kit with NIBP |
| 00843997010337 | Radius VSM Kit with Reusable Pod & NIBP |
| 00843997009430 | Radius VSM NIBP Module, 1/Box |
| 00843997009065 | Radius VSM Multi-functional Reusable Pod, 1/Box |
| 00843997016018 | Radius VSM ECG Electrode Set Adult 3-Lead Set |
| 00843997011006 | Radius VSM - ECG Electrode Set, Adult 3-Lead, AAMI/AHA |
Trademark Results [Radius VSM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RADIUS VSM 88681229 not registered Live/Pending |
MASIMO CORPORATION 2019-11-05 |
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