Levl 1

by Medamonitor, LLC

Listed FDA GUDID listing, no authorization on record

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	NumberG338KIT0041 UDI-DI	Date13 Sep 2022Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Levl
Generic Name: Breath ketone IVD, kit, rapid colorimetric, clinical
Model / Ref / Catalog: 1, KIT004

Primary DI / UDI-DI: G338KIT0041
FDA Product Code: LXG
GMDN Term: Breath ketone IVD, kit, rapid colorimetric, clinical

Device Class: Class I
Regulation Number: 862.2050
GUDID distribution status: In Commercial Distribution

Properties

Prescription Use
Premarket Exempt
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (9)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No