Pneupac

FDA UDIEUDAMED

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Pneupac FDA UDI
Generic Name: Transport electric ventilator FDA UDI
Model / Reference: 130002 FDA UDI

Identifiers

Primary DI / UDI-DI: 10610586045561 FDA UDI
510(k) Number: K030803 FDA UDI
FDA Product Code: BTL FDA UDI
GMDN Term: Transport electric ventilator 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

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

MRI Safety

MR Conditional FDA UDI

Category: Transport electric ventilator

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

Similar devices

Also classified as Transport electric ventilator.

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Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
VENT — Zoll Medical Corporation · Class II
PATIENT CIRCUITS — Zoll Medical Corporation · Class II
Z Vent — Zoll Medical Corporation · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II

Cleared under the same submission

K030803 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Icu Medical, Inc.

Sources (2)

FDA UDI 51918ced-44ad-44d8-9d5b-c6272c84f5da 33 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 2, 2026