Celerity

Basic Information

• Brand Name: Celerity
• Primary DI: 00724995215941
• Version / Model: LCB060
• Catalog Number: LCB060
• Company Name: STERIS CORPORATION
• Labeler DUNS: 868205779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-23
• Public Version: 2
• Public Version Date: 2023-08-11
• Public Version Status: Update
• Public Device Record Key: a97a7677-ef26-4f9f-8e77-dd6a48826657

Device Description

The Celerity Incubator is used to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55-60 Degrees Celsius for a fluorescent result.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRC	Indicator, biological sterilization process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46944	Test tube heater	An electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995215941	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K213881	000
K223715	000