Lifecare PCA

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Lifecare PCA FDA UDI
Generic Name: Patient-controlled analgesia infusion pump FDA UDI
Device Name: PCA 7.X w/ MedNet FDA UDI
Model / Reference: 208370402 FDA UDI
Description: PCA 7.X w/ MedNet FDA UDI

Identifiers

Catalog Number: 20837 FDA UDI
Primary DI / UDI-DI: M3352083704021 FDA UDI
510(k) Number: K143612 FDA UDI
FDA Product Code: MEA FDA UDI
GMDN Term: Patient-controlled analgesia infusion pump FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 15.875 Inch FDA UDI
Length — 13.125 Inch FDA UDI
Depth — 11.75 Inch FDA UDI

Category: Patient-controlled analgesia infusion pump

Lifecare PCA by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Patient-controlled analgesia infusion pump.

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Nimbus — INFUTRONIX LLC · Class II
Lifecare PCA — Hospira, Inc. · Class II
Nimbus — INFUTRONIX LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Icu Medical, Inc.

Sources (1)

FDA UDI e85f5fc2-c367-4c76-86fd-3c2a2eade6e6 38 fields · synced Jun 8, 2026