Primary Device ID | 00843997017923 |
NIH Device Record Key | 64f6864f-553b-4bf1-ad3d-f531a3a7602f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RD rainbow |
Version Model Number | 5306 |
Company DUNS | 780421038 |
Company Name | MASIMO CORPORATION |
Device Count | 10 |
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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843997017923 [Unit of Use] |
GS1 | 10843997017920 [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 |
00843997010894 | RD rainbow Neo 8 lambda Adult/Neonatal Pulse CO-Oximeter Adhesive Sensor |
00843997010887 | RD rainbow Inf 8 lambda Infant Pulse CO-Oximeter Adhesive Sensor |
00843997010870 | RD rainbow Pdt 8 lambda Pediatric/Slender digit Pulse CO-Oximeter Adhesive Sensor |
00843997010863 | RD rainbow Adt 8 lambda Adult Pulse CO-Oximeter Adhesive Sensor |
00843997015776 | RD rainbow Neo 4 lambda Adult/Neonatal Pulse CO-Oximeter Adhesive Sensor |
00843997015769 | RD rainbow Inf 4 lambda Infant Pulse CO-Oximeter Adhesive Sensor |
00843997015752 | RD rainbow Pdt 4 lambda Pediatric/Slender digit Pulse CO-Oximeter Adhesive Sensor |
00843997015745 | RD rainbow Adt 4 lambda Pulse CO-OximeterAdhesive Sensor |
00843997015943 | RD rainbow 4 lambda Training Kit |
00843997017923 | RD rainbow Adt 8 LiDCO SpHb ORi Adhesive Sensor, 10/Box |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RD RAINBOW 90707338 not registered Live/Pending |
Masimo Corporation 2021-05-12 |