FDA UDI
In Commercial Distribution
🇺🇸 United States
Wireless Pulse Oximetry Sensor for TeslaDUO
DI: 04255629200553
·
Model: Wireless Pulse Oximetry Sensor for TeslaDUO
·
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Wireless Pulse Oximetry Sensor for TeslaDUO
- Primary DI
- 04255629200553
- Version / Model
- Wireless Pulse Oximetry Sensor for TeslaDUO
- Catalog Number
- 5010101
- Company Name
- MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Labeler DUNS
- 324416379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-25
- Public Version
- 1
- Public Version Date
- 2024-02-02
- Public Version Status
- New
- Public Device Record Key
- cbb21902-f00d-4a9e-b9f9-2e33b1f55505
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
- Yes
- 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 | 04255629200553 | GS1 | ||||
| Previous | EMIP50101010 | HIBCC |
Customer Contacts
- Phone
- +49814592090
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153739 | 000 |