FDA UDI
In Commercial Distribution
🇺🇸 United States
NPS2 Tempus Pro
DI: 04057834083439
·
Model: 095097-001
·
RAUMEDIC AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NPS2 Tempus Pro
- Primary DI
- 04057834083439
- Version / Model
- 095097-001
- Company Name
- RAUMEDIC AG
- Labeler DUNS
- 332785323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-13
- Public Version
- 3
- Public Version Date
- 2023-12-13
- Public Version Status
- Update
- Public Device Record Key
- 5c42eef7-ecd1-4ce3-a57f-b63df63eae1a
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 |
|---|---|---|---|---|
| 61435 | Intracranial/compartmental-pressure monitor calibrator/cable | An electronic device intended to generate a reference baseline for the standardization of readings of intracranial pressure (ICP) and/or pressure in a muscle compartment, and to transfer the readings from a catheter (i.e., intracerebral sensor or compartmental-pressure catheter) to a pressure monitor. It consists of a small unit with input and output cables to make electrical connections between a catheter connection cable and the patient monitor. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04057834083439 | GS1 |
Customer Contacts
- Phone
- +4992523590
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius