Lucas Lifecare

GUDID 00860014827310

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.

Lucas Lifecare, LLC

Steam sterilizer

• Primary Device ID: 00860014827310
• NIH Device Record Key: bc0170ce-c86b-419f-856a-a19e1b3d4ccd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lucas Lifecare
• Version Model Number: LifeUltra
• Company DUNS: 089663452
• Company Name: Lucas Lifecare, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014827310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250168

FDA Product Code

• FLE: Sterilizer, Steam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-05
• Device Publish Date: 2026-01-28

Devices Manufactured by Lucas Lifecare, LLC

• 00860014827310 - Lucas Lifecare: 2026-02-05Life 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.
• 00860014827310 - Lucas Lifecare: 2026-02-05 Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is a fully automatic tabletop steam sterilizer that uses saturated steam u
• 00860014827303 - LifeRay: 2025-12-05 The Lucas Lifecare’s LifeRay handheld is indicated for use only by a trained and qualified dentist or dental technicians for