Nonin
GUDID 00833166007688
Regional Sensor
NONIN MEDICAL, INC.
Cerebral oximeter sensor, single-use| Primary Device ID | 00833166007688 |
| NIH Device Record Key | 1b379307-b1fd-43e8-9446-466ac980a3fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nonin |
| Version Model Number | 8000CA |
| Company DUNS | 174959692 |
| Company Name | NONIN MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com | |
| Phone | 1.800.356.8874 |
| Regulatory@nonin.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00833166000986 [Package] Contains: 00849686074147 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 00833166007688 [Package] Contains: 00849686074147 Package: Box [20 Units] In Commercial Distribution |
| GS1 | 00849686074147 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090807
FDA Product Code
| MUD | Oximeter, Tissue Saturation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2016-08-24 |
On-Brand Devices [Nonin]
| 00833166001907 | Soft Sensor, Large |
| 00849686066951 | Wearable pulse oximeter |
| 00849686070354 | Power Supply, LS1 |
| 00849686088151 | 7600PA Sensor Lock |
| 00849686086188 | 7600PA Sensor Lock |
| 00849686085983 | Pole Mount clamp |
| 00849686070330 | Battery Pack |
| 00849686075571 | Intermediate Cable |
| 00849686075410 | RTC Cable |
| 00849686070347 | Battery Pack |
| 00849686071993 | NoninConnect Elite™ Model 3240 Bluetooth® Smart Pulse Oximeter |
| 00833166000689 | Reflectance Pulse Oximeter Sensor |
| 00849686071405 | Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology |
| 00849686085808 | Adult Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Techn |
| 00849686070699 | Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology |
| 00849686085747 | Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology |
| 00833166000009 | PalmSAT Handheld Pulse Oximeter |
| 00849686090178 | 2500A Handheld Pulse Oximeter with Alarms |
| 00833166000757 | Ear Clip Pulse Oximeter Sensor |
| 00833166005950 | Interface Cable |
| 00833166002188 | Reusable Adult Flex Pulse Oximeter Sensor and Model 8000JFW FlexiWrap® Single Use Sensor Wrap, |
| 00833166004717 | Reusable Adult Flex Pulse Oximeter Sensor and Model 8000JFW FlexiWrap® Single Use Sensor Wrap |
| 00833166003536 | Reusable Adult Flex Pulse Oximeter Sensor, 20 CM and FlexiWrap® Single Use Sensor Wrap, |
| 00833166000610 | Flex Sensor and FlexiWrap |
| 00833166000603 | Flex Sensor and FlexiWrap® |
| 00833166000085 | Onyx Finger Pulse Oximeter |
| 00833166002355 | Carbon Dioxide Sensor |
| 00833166000740 | Reusable Adult Flex Pulse Oximeter Sensor and Model 8000JFW FlexiWrap® Single Use Sensor Wrap |
| 00833166009767 | Pulse Oximeter |
| 00849686089899 | Handheld Pulse Oximeter with CO2 Detector |
| 00849686089882 | Handheld Pulse Oximeter with CO2 Detector and Alarm |
| 00833166000719 | Fiber Optic Pulse Oximeter Sensor |
| 00833166000702 | Fiber Optic Pulse Oximeter Sensor |
| 00833166000733 | Fiber Optic Pulse Oximeter Sensor |
| 00833166000726 | Fiber Optic Pulse Oximeter Sensor |
| 00833166003567 | Handheld Pulse Oximeter |
| 00833166000078 | Handheld Pulse Oximeter |
| 00833166007688 | Regional Sensor |
| 00833166002850 | Regional Oximeter, 2-Channel |
| 00833166001549 | GO2 Finger Oximeter, Blue |
| 00833166001594 | GO2 Finger Pulse Oximeter, Orange |
| 00833166008340 | GO2 Finger Pulse Oximeter, Red |
| 00833166001556 | GO2 Finger Pulse Oximeter, Green |
| 00833166008364 | GO2 Finger Pulse Oximeter, Pink |
| 00833166008371 | GO2 Finger Pulse Oximeter, White |
| 00833166001181 | GO, 9570 |
| 00833166003390 | WristOx2 Wearable Pulse Oximeter with Bluetooth |
| 00849686067606 | Regional Oximeter |
| 00833166003437 | Reusable Adult Flex Pulse Oximeter Sensor and Model 8000JFW FlexiWrap® Single Use Sensor Wrap |
| 00833166008722 | charger stand |
Trademark Results [Nonin]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NONIN 74410980 1839315 Live/Registered |
Nonin Medical, Inc. 1993-07-12 |
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