Nonin
GUDID 00849686072655
Reusable Soft Pulse Oximeter Sensor
NONIN MEDICAL, INC.
Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable| Primary Device ID | 00849686072655 |
| NIH Device Record Key | 6189aa30-380a-43d3-8cd5-6ba688430866 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nonin |
| Version Model Number | 8000SS-WO |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| Regulatory@nonin.com | |
| Phone | 763 553 9968 |
| 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 |
| 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 Celsius and 70 Degrees Celsius |
| 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 Celsius and 70 Degrees Celsius |
| 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 Celsius and 70 Degrees Celsius |
| 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 Celsius and 70 Degrees Celsius |
| 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 Celsius and 70 Degrees Celsius |
| 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 Celsius and 70 Degrees Celsius |
| 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 Celsius and 70 Degrees Celsius |
| 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 Celsius and 70 Degrees Celsius |
| 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 Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849686072655 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102350
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 | 4 |
| Public Version Date | 2020-12-10 |
| 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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