Primary Device ID | 00843997012812 |
NIH Device Record Key | dca1b172-7987-40f9-bfbc-81375d785177 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Rad-67 |
Version Model Number | 9794 |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
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 | |
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 | |
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 -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843997012812 [Primary] |
GS1 | 00843997013697 [Direct Marking] |
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 | 2020-09-11 |
Device Publish Date | 2020-09-03 |
00843997014618 | Rad-67 Pulse CO-Oximeter with rainbow DCI mini sensor |
00843997014601 | Rad-67 Pulse CO-Oximeter with rainbow DCI mini sensor |
00843997014595 | Rad-67 Pulse CO-Oximeter with rainbow DCI mini sensor |
00843997012812 | Pulse CO-Oximeter |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RAD-67 87112038 not registered Live/Pending |
Masimo Corporation 2016-07-21 |
RAD-67 85577302 not registered Dead/Abandoned |
Masimo Corporation 2012-03-22 |