Nonin
- Primary DI
- 00849686086560
- Brand
- Nonin
- Company
- NONIN MEDICAL, INC.
- Model
- X-100SP-5
- Device description
- Universal Oximetry Signal Processor, Channel 5
- 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 |
|---|
| 00833166002034 | Package | GS1 | 1 | In Commercial Distribution |
| 00849686066159 | Package | GS1 | 1 | In Commercial Distribution |
| 00849686075649 | Package | GS1 | 1 | In Commercial Distribution |
| 00849686086560 | Package | GS1 | 1 | In Commercial Distribution |
| 00849686072846 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00833166002034 | 00833166002034 | 833166002034 | 0833166002034 |
| 00849686066159 | 00849686066159 | 849686066159 | 0849686066159 |
| 00849686075649 | 00849686075649 | 849686075649 | 0849686075649 |
| 00849686086560 | 00849686086560 | 849686086560 | 0849686086560 |
| 00849686072846 | 00849686072846 | 849686072846 | 0849686072846 |
GMDN Terms
| Term | Definition |
|---|
| Cerebral oximeter | A mains electricity (AC-powered) photoelectric device that noninvasively measures the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is typically used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a paediatric or adult patient. It uses a cerebral sensor(s) having a light source and photodiode detector that is/are placed on the scalp/head. Position-1 detector detects infrared light absorption of extracranial blood and position-2 detector detects infrared light absorption of cerebral blood. Cerebral oxygenation is calculated by subtracting the absorption measured at site 1 from that measured at site 2. |
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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