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PiCCO Module

FDA UDI

Class II (US FDA UDI)

by Pulsion Medical Systems SE

Identity

Trade Name
PiCCO Module FDA UDI
Generic Name
Patient monitoring system module, cardiac output FDA UDI
Model / Reference
PC4510 FDA UDI

Identifiers

Primary DI / UDI-DI
04250094501402 FDA UDI
510(k) Number
K122121 FDA UDI
K172259 FDA UDI
FDA Product Code
DXG FDA UDI
GMDN Term
Patient monitoring system module, cardiac output FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1435 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient monitoring system module, cardiac output

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

Similar devices

Also classified as Patient monitoring system module, cardiac output.

Cleared under the same submission

K122121 also covers:

K172259 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 23b33c78-bf60-43be-b804-dbbf96bb544b 34 fields · synced Jun 8, 2026