Pneupac

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Pneupac FDA UDI
Generic Name: Pulmonary resuscitator, pneumatic, reusable FDA UDI
Model / Reference: 520A1300US FDA UDI

Identifiers

Primary DI / UDI-DI: 10610586045738 FDA UDI
510(k) Number: K051322 FDA UDI
FDA Product Code: BTL FDA UDI
GMDN Term: Pulmonary resuscitator, pneumatic, reusable 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: Pulmonary resuscitator, pneumatic, reusable

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

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Cleared under the same submission

K051322 also covers:

Pneupac — ICU MEDICAL, INC.
Pneupac — ICU MEDICAL, INC.

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 2899a0ce-bff5-431a-b86c-bae6352f084b 33 fields · synced May 30, 2026