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Pneupac

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
Pneupac FDA UDI
Generic Name
Neonatal intensive-care ventilator FDA UDI
Model / Reference
B100NUS FDA UDI

Identifiers

Primary DI / UDI-DI
35019315071892 FDA UDI
510(k) Number
K043495 FDA UDI
FDA Product Code
BTL FDA UDI
GMDN Term
Neonatal intensive-care 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

Yes

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 Unsafe FDA UDI

Category: Neonatal intensive-care ventilator

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

Similar devices

Also classified as Neonatal intensive-care ventilator.

Cleared under the same submission

K043495 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 e84e71fb-c385-418f-94b2-0ebe681f7def 33 fields · synced May 31, 2026