Primary Device ID | 00843997003391 |
NIH Device Record Key | 78a2bccb-ea83-4ad5-9ef8-1f7e4c2a0d8d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LNCS |
Version Model Number | 2691 |
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 |
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 Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
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 Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
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 Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
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 Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
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 Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
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 Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
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 Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
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 Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
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 Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
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 Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
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 Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
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 Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843997003391 [Unit of Use] |
GS1 | 10843997003398 [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 | 2024-08-26 |
Device Publish Date | 2024-08-16 |
00843997008860 | LNCS TFA-1 Adult/Pediatric Disposable Transflectance Sensor |
00843997015967 | Pdtx/Inf/Neo Sensor Kit |
00843997015950 | Adtx Sensor Kit |
00843997017350 | LNCS Neo Newborn Adhesive Sensor, 20/Box, Masimo |
00843997003414 | LNCS Neo-3 Adhesive Sensor Reprocessed, 20/Box, Masimo |
00843997003407 | LNCS Neo Adhesive Sensor Reprocessed, 20/Box, Masimo |
00843997003391 | LNCS Inf-3 Adhesive Sensor Reprocessed, 20/Box, Masimo |
00843997003384 | LNCS Inf Adhesive Sensor Reprocessed, 20/Box, Masimo |
00843997003346 | LNCS Adtx-3 Adhesive Sensor Reprocessed, 20/Box, Masimo |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LNCS 78253760 2968413 Live/Registered |
Masimo Corporation 2003-05-23 |