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Pneupac

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

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

Identifiers

Primary DI / UDI-DI
10610586045622 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Transport electric ventilator

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

Similar devices

Also classified as Transport electric ventilator.

Cleared under the same submission

K030803 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI adacefe5-1550-4f73-88f1-593e54d2df5e 33 fields · synced May 30, 2026