LNCS® Sensor Sample Pack
GUDID 10843997003916
MASIMO CORPORATION
Pulse oximeter probe, single-use| Primary Device ID | 10843997003916 |
| NIH Device Record Key | 0ac35b52-c93b-498f-99ad-26ded672bfb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LNCS® Sensor Sample Pack |
| Version Model Number | 2346 |
| 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 | 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 | |
| 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 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10843997003916 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101896
FDA Product Code
| DQA | Oximeter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-11-10 |
| Device Publish Date | 2016-08-24 |
On-Brand Devices [LNCS® Sensor Sample Pack]
| 10843997003916 | 2346 |
| 10843997000601 | 1899 |
Trademark Results [LNCS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LNCS 78253760 2968413 Live/Registered |
Masimo Corporation 2003-05-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.