← Back to catalogue

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
510A1960NONEU FDA UDI

Identifiers

Primary DI / UDI-DI
15019517181173 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI 67ffff5b-1f1c-4951-8e25-0f5ac29f3551 34 fields · synced Jun 6, 2026