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PiCCO Catheter

FDA UDI

Class II (US FDA UDI)

by Pulsion Medical Systems SE

Identity

Trade Name
PiCCO Catheter FDA UDI
Generic Name
Thermal dilution peripheral artery catheter FDA UDI
Device Name
4F Thermodilution catheter, 220mm FDA UDI
Model / Reference
PV2014L22-A FDA UDI
Description
4F Thermodilution catheter, 220mm FDA UDI

Identifiers

Primary DI / UDI-DI
04250094500979 FDA UDI
510(k) Number
K171620 FDA UDI
FDA Product Code
KRB FDA UDI
GMDN Term
Thermal dilution peripheral artery catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1915 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 4 French FDA UDI
Length — 220 Millimeter FDA UDI

Category: Thermal dilution peripheral artery catheter

PiCCO Catheter by Pulsion Medical Systems SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thermal dilution peripheral artery catheter.

Cleared under the same submission

K171620 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pulsion Medical Systems SE

Sources (1)

  • FDA UDI 19038862-b2cc-417d-8371-6ffb33b04449 36 fields · synced May 31, 2026