Eclipse 3

FDA UDI

Class II (US FDA UDI)

by Caire Inc.

Identity

Trade Name: ECLIPSE 3 FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: OXYGEN CONCENTRATOR, PORTABLE, 3LPM, SYS, EN, EURO FDA UDI
Model / Reference: 5909-SEQ FDA UDI
Description: OXYGEN CONCENTRATOR, PORTABLE, 3LPM, SYS, EN, EURO FDA UDI

Identifiers

Primary DI / UDI-DI: M7665909SEQ0 FDA UDI
510(k) Number: K013931 FDA UDI
FDA Product Code: CAW FDA UDI
GMDN Term: Mobile/portable oxygen concentrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5440 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

Category: Mobile/portable oxygen concentrator

Eclipse 3 by Caire Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K013931 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: Caire Inc.

Sources (1)

FDA UDI cc7f35e0-5cb8-4741-bff3-0f8abc484a5c 34 fields · synced Jun 8, 2026