FDA UDI
In Commercial Distribution
🇺🇸 United States
MPR2 logO DATALOGGER
DI: 04057834073591
·
Model: 095274-001
·
RAUMEDIC AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MPR2 logO DATALOGGER
- Primary DI
- 04057834073591
- Version / Model
- 095274-001
- Company Name
- RAUMEDIC AG
- Labeler DUNS
- 332785323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-09
- Public Version
- 4
- Public Version Date
- 2023-12-13
- Public Version Status
- Update
- Public Device Record Key
- e77a76fb-74f4-4c2d-9474-6adaabd9a7d5
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | Neurology | 882.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61452 | Invasive-detection multi-parameter physiological monitor, reusable | An electrically-powered device intended for the continuous or intermittent measurement, display, and/or recording of several invasively-detected physiological parameters [e.g., blood pressure, intracranial pressure (ICP), temperature, and partial pressure of oxygen (pO2)]. It consists of a single unit intended to be used with an invasive access device(s) [e.g., arterial blood pressure catheter, intracerebral sensor catheter] (not included) which signals the monitor via connected cables. It may be a portable device that can be attached to the patient with a strap and may include alarms designed to alert clinical staff. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04057834073591 | GS1 |
Customer Contacts
- Phone
- +4992523590
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity