Nellcor OxySoft
- Primary DI
- 20884521819006
- Company
- Covidien LP
- Model
- OxySoftNCov
- Device description
- Neonatal-Adult SpO2 Sensor;OxiMax TM Technology
- Published
- 2022-08-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Regulatory Flags
- DUNS number
- 058614483
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20884521819006 | Package | GS1 | 24 | In Commercial Distribution |
| 10884521819009 | Primary | GS1 | 0 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|---|---|---|---|---|---|---|
| 20884521819006 | Package | GS1 | 24 | CASE | 10884521819009 | In Commercial Distribution | |
| 10884521819009 | Primary | GS1 | 0 |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|---|---|---|---|---|---|
| DQA | Oximeter | 2 | Cardiovascular | 870.2700 | N | Eligible |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K212555 | 000 |
Premarket Details
GMDN Terms
| Term | Definition |
|---|---|
| Pulse oximeter probe, single-use | A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device. |
Device Sizes
| Type | Value | Text |
|---|---|---|
| Device Size Text, specify | 0 | Weight, less than 3 or greater than 40, kg; |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Atmospheric Pressure | 0.5 KiloPascal | 1.06 KiloPascal | |
| Handling Environment Atmospheric Pressure | 50 KiloPascal | 106 KiloPascal | |
| Handling Environment Atmospheric Pressure | 62 KiloPascal | 106 KiloPascal | |
| Handling Environment Humidity | 15 Percent (%) Relative Humidity | 95 Percent (%) Relative Humidity | |
| Handling Environment Temperature | -40 Degrees Celsius | 70 Degrees Celsius | |
| Handling Environment Temperature | 0 Degrees Celsius | 40 Degrees Celsius | |
| Special Storage Condition, Specify | 0 | 0 | Keep dry |
| Storage Environment Atmospheric Pressure | 0.62 KiloPascal | 1.06 KiloPascal | |
| Storage Environment Atmospheric Pressure | 50 KiloPascal | 106 KiloPascal | |
| Storage Environment Atmospheric Pressure | 62 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 15 Percent (%) Relative Humidity | 95 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -40 Degrees Celsius | 70 Degrees Celsius | |
| Storage Environment Temperature | 0 Degrees Celsius | 40 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(508)261-8000 | covidien.udi@covidien.com |
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 20884521841724 | Shiley | 50FXLTCP | 2026-03-17 | |
| 20884521841687 | Shiley | 50FXLTCD | 2026-03-16 | |
| 20884521841694 | Shiley | 60FXLTCD | 2026-03-16 | |
| 20884521841700 | Shiley | 70FXLTCD | 2026-03-16 | |
| 20884521841717 | Shiley | 80FXLTCD | 2026-03-16 | |
| 20884521841731 | Shiley | 60FXLTCP | 2026-03-16 | |
| 20884521841748 | Shiley | 70FXLTCP | 2026-03-16 | |
| 20884521841755 | Shiley | 80FXLTCP | 2026-03-16 | |
| 20884521841762 | Shiley | 50FXLTUD | 2026-03-16 | |
| 20884521841779 | Shiley | 60FXLTUD | 2026-03-16 | |
| 20884521841786 | Shiley | 70FXLTUD | 2026-03-16 | |
| 20884521841793 | Shiley | 80FXLTUD | 2026-03-16 | |
| 20884521841809 | Shiley | 50FXLTUP | 2026-03-16 | |
| 20884521841816 | Shiley | 60FXLTUP | 2026-03-16 | |
| 20884521841823 | Shiley | 70FXLTUP | 2026-03-16 | |
| 20884521841830 | Shiley | 80FXLTUP | 2026-03-16 | |
| 30884521841844 | Shiley | 50FXLTIN | 2026-03-16 | |
| 20884521841854 | Shiley | 60FXLTIN | 2026-03-16 | |
| 20884521841861 | Shiley | 70FXLTIN | 2026-03-16 | |
| 20884521841878 | Shiley | 80FXLTIN | 2026-03-16 |