Pneupac

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Pneupac FDA UDI
Generic Name: Ventilator breathing circuit, single-use FDA UDI
Model / Reference: 122202 FDA UDI

Identifiers

Primary DI / UDI-DI: 10610586045509 FDA UDI
510(k) Number: K020899 FDA UDI
FDA Product Code: BTL FDA UDI
GMDN Term: Ventilator breathing circuit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5925 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ventilator breathing circuit, single-use

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

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Also classified as Ventilator breathing circuit, single-use.

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HUDSON RCI — TELEFLEX INCORPORATED · Class II
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Classic RT — Plastiflex Group NV · Class I

Cleared under the same submission

K020899 also covers:

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 ceacb671-51b3-4933-a3ee-a3c35a095de6 33 fields · synced May 30, 2026