FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PiCCO Catheter
DI: 04250094500634
·
Model: PV2013L07N
·
Pulsion Medical Systems SE
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PiCCO Catheter
- Primary DI
- 04250094500634
- Version / Model
- PV2013L07N
- Company Name
- Pulsion Medical Systems SE
- Labeler DUNS
- 316093673
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2021-10-13
- Public Version Status
- Update
- Public Device Record Key
- 77978c7e-0155-415f-a6a4-9c51d087c87e
- Distribution End Date
- 2021-10-12
Device Description
3F Thermodilution catheter, 7cm
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
- Labeling does not contain MRI Safety Information
- 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 | 24250094500638 | GS1 | Box | 10 | Not in Commercial Distribution | 2021-10-12 |
| Package | 14250094500631 | GS1 | Box | 5 | Not in Commercial Distribution | 2021-10-12 |
| Primary | 04250094500634 | GS1 |
Customer Contacts
- Phone
- +490894599140
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072364 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 3 | French | |
| Length | 7 | Centimeter |