FDA UDI
In Commercial Distribution
🇺🇸 United States
Expression MR Wireless SpO2 Patient Module (Gen 3)6-10
DI: 00884838055032
·
Model: Wireless SpO2 3.0 Module (Networks 6-10)
·
Philips Ds North America LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Expression MR Wireless SpO2 Patient Module (Gen 3)6-10
- Primary DI
- 00884838055032
- Version / Model
- Wireless SpO2 3.0 Module (Networks 6-10)
- Catalog Number
- 989803194331
- Company Name
- Philips Ds North America LLC
- Labeler DUNS
- 013649151
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-29
- Public Version
- 11
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- 7cc72769-46ba-44fd-9cc6-ac86d5a9833b
Device Description
3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 6-10).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MWI | MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36554 | Patient monitoring system module, pulse oximetry | A small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838055032 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 708 – 1020 millibar
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 531 – 765 Millimeter of Mercury