Lucas Lifecare

Primary DI
00860014827310
Brand
Lucas Lifecare
Company
Lucas Lifecare, LLC
Model
LifeUltra
Device description
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is a fully automatic tabletop steam sterilizer that uses saturated steam under pressure to sterilize heat- and moisture-resistant reusable loads (solid, hollow, porous, or delicate) in wrapped or unwrapped configurations for medical, dental, surgical, healthcare, and laboratory settings. The unit incorporates a vacuum system for dynamic air removal to support steam penetration, temperature uniformity, and post-sterilization drying (drying with door closed). The sterilizer is microcontroller-controlled with installed software and pre-set sterilization programs, providing validated Class B and Class S cycles along with test cycles including Vacuum Test and Bowie-Dick Test.
Published
2026-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250168000Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare2025-12-30FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014827310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014827310008600148273108600148273100860014827310

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
089663452
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014827303LifeRayA02010002025-10-21

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