Avea 11395

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10846446001204 UDI-DI	Date28 Sep 2015Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Avea
Generic Name: Neonatal/adult intensive-care ventilator
Model / Reference: 11395

Primary DI / UDI-DI: 10846446001204
FDA Product Code: CBK
GMDN Term: Neonatal/adult intensive-care ventilator

Device Class: Class II
Regulation Number: 868.5895
GUDID distribution status: Not in Commercial Distribution

MRI Safety: MR Unsafe

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Properties

Single Use
Prescription Use
Lot / Batch Number

Other properties (11)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No