FDA UDI
In Commercial Distribution
🇺🇸 United States
PiCCO Catheter
DI: 04250094500962
·
Model: PV2014L16-A
·
Pulsion Medical Systems SE
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PiCCO Catheter
- Primary DI
- 04250094500962
- Version / Model
- PV2014L16-A
- Company Name
- Pulsion Medical Systems SE
- Labeler DUNS
- 316093673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-12
- Public Version
- 3
- Public Version Date
- 2021-10-13
- Public Version Status
- Update
- Public Device Record Key
- eed103d9-2c9c-495a-a5b2-2f810fc003d9
Device Description
4F Thermodilution catheter, 160mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KRB | Probe, Thermodilution | Cardiovascular | 870.1915 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64576 | Thermal dilution peripheral artery catheter | A short, thin, flexible tube intended for short-term (<= 30 days) percutaneous placement into a peripheral artery (excluding pulmonary artery) during measurement/monitoring of haematological parameters (e.g., arterial pressure, cardiac output/index) using thermal dilution techniques. It is designed to be used as the downstream sensor during thermal dilution, whereby it is intended to be used in conjunction with a central venous catheter (intended for upstream solution introduction) and an external monitor. It includes an electronic thermistor and may include devices dedicated to introduction/function. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24250094500966 | GS1 | Box | 10 | In Commercial Distribution | |
| Package | 14250094500969 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 04250094500962 | GS1 |
Customer Contacts
- Phone
- +49894599140
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171620 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 4 | French | |
| Length | 160 | Millimeter |