EOlife ECU

FDA UDI

Class II (US FDA UDI)

by Archeon

Identity

Trade Name: EOlife ECU FDA UDI
Generic Name: Pulmonary resuscitator, manual, reusable FDA UDI
Device Name: EOlife ECU (ref: AUS00004) is the Electronic Control Unit of the EOlife device (ref: AUS00055). FDA UDI
Model / Reference: AUS00004 FDA UDI
Description: EOlife ECU (ref: AUS00004) is the Electronic Control Unit of the EOlife device (ref: AUS00055). FDA UDI

Identifiers

Primary DI / UDI-DI: 03770016085052 FDA UDI
510(k) Number: K221841 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Pulmonary resuscitator, manual, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5915 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Pulmonary resuscitator, manual, reusable

EOlife ECU by Archeon — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K221841 also covers:

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: Archeon

Sources (1)

FDA UDI 670bd910-be14-4ada-ac8d-7ffd492c7afe 34 fields · synced May 30, 2026