Nonin
- Primary DI
- 00849686086591
- Brand
- Nonin
- Company
- NONIN MEDICAL, INC.
- Model
- X-100SP-2
- Device description
- Universal Oximetry Signal Processor, Channel 2
- Published
- 2016-08-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| MUD | Oximeter, Tissue Saturation |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MUD | Oximeter, Tissue Saturation | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00833166002065 | Package | GS1 | 1 | In Commercial Distribution |
| 00849686086591 | Package | GS1 | 1 | In Commercial Distribution |
| 00849686072877 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00833166002065 | 00833166002065 | 833166002065 | 0833166002065 |
| 00849686086591 | 00849686086591 | 849686086591 | 0849686086591 |
| 00849686072877 | 00849686072877 | 849686072877 | 0849686072877 |
GMDN Terms
| Term | Definition |
|---|
| Pulse oximeter, battery-powered | A portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | -30 Degrees Celsius | 70 Degrees Celsius | |
| Storage Environment Temperature | -22 Degrees Fahrenheit | 158 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 174959692
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
| 00849686052367 | MODEL 3150, WRIST-OX2, BLE | 3150 | | 2024-11-21 |
| 00849686051698 | HANDHELD PULSE OXIMETER | 8500, PULSE OXIMETER | | 2024-09-17 |
| 00849686065855 | HANDHELD PULSE OXIMETER | 2500C, PULSE OXIMETER CHARGER | | 2024-09-17 |
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| 00849686070637 | RESUSABLE PULSE OXIMETRY SENSOR SYSTEM | 8100Q2, REUSABLE EAR CLIP SENSOR | | 2024-09-17 |
| 00849686085976 | REUSABLE PULSE OXIMETRY SOFT SENSORS | 70276, MODEL 8000JFW ADULT FLEXW DISP | | 2024-09-17 |
| 00833166000122 | PALMSAT HANDHELD OXIMETER | 2500,8000SM | | 2024-09-10 |
| 00833166000139 | PALMSAT HANDHELD OXIMETER | 2500, 8000SM-3 | | 2024-09-10 |
| 00833166000146 | PALMSAT HANDHELD OXIMETER | 2500, 8000SL | | 2024-09-10 |
| 00833166004410 | RESUSABLE PULSE OXIMETRY SENSOR SYSTEM | EMBLA 8000J 3M | | 2024-09-10 |
| 00833166009859 | FINGERTIP PULSE OXIMETER | 9590 BLUE, OXIMETER | | 2024-09-10 |
| 00833166009866 | FINGERTIP PULSE OXIMETER | 9590 RED, OXIMETER | | 2024-09-10 |
| 00833166000054 | PALMSAT HANDHELD OXIMETER | 2500, 8001J | | 2024-09-09 |
| 00849686050981 | WristOx2 Model 3150SC USB Comm Cable, Philips | 3150SC | | 2021-04-05 |
| 00849686050998 | Soft Sensor Large WO2 Model 8000SL-WO2 | 8000SL-WO2 | | 2021-04-05 |
| 00849686051001 | Soft Sensor Medium WO2 Model 8000SM-WO2 | 8000SM-WO2 | | 2021-04-05 |
| 00849686051018 | Soft Sensor Small WO2 Model 8000SS-WO2 | 8000SS-WO2 | | 2021-04-05 |
| 00849686051025 | WristOx2 Model 3150 with Bluetooth Low Energy | 3150 | | 2021-04-05 |
| 00833166004113 | Nonin | 3150SC | | 2016-09-03 |
| 00849686070972 | Nonin | 7500 Analog Cable | | 2016-09-03 |
Other Devices Sharing Product Codes
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