3100B Hfov 26213-001

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	Number10846446062540 UDI-DI	Date24 Sep 2014Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: 3100B Hfov
Generic Name: Stationary electric high-frequency ventilator
Model / Ref / Catalog: 26213-001

Primary DI / UDI-DI: 10846446062540
FDA Product Code: LSZ
GMDN Term: Stationary electric high-frequency ventilator

Device Class: Class III
GUDID distribution status: Not in Commercial Distribution

MRI Safety: MR Unsafe

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Properties

Prescription Use
Convenience Kit
Serial Number

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No
Manufacturing Date: No