FDA UDI
In Commercial Distribution
🇺🇸 United States
PiCCO catheter
DI: 27325710011601
·
Model: PV2015L20
·
Maquet Critical Care AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- PiCCO catheter
- Primary DI
- 27325710011601
- Version / Model
- PV2015L20
- Catalog Number
- 6885049
- Company Name
- Maquet Critical Care AB
- Labeler DUNS
- 632707092
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2026-03-24
- Public Version
- 1
- Public Version Date
- 2026-04-01
- Public Version Status
- New
- Public Device Record Key
- f258a86f-6c0d-4673-94dc-ef7ee0be5968
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 07325710011607 | GS1 | ||||
| Primary | 27325710011601 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171620 | 000 |