Celerity

Basic Information

• Brand Name: Celerity
• Primary DI: 10724995215924
• Version / Model: LCB052
• Catalog Number: LCB052
• Company Name: STERIS CORPORATION
• Labeler DUNS: 961394798
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2023-08-08
• Public Version: 1
• Public Version Date: 2023-08-16
• Public Version Status: New
• Public Device Record Key: b6ce05cf-b3fd-4bc5-9595-34acb4bea574

Device Description

The Celerity 5 HP Biological Indicator is used for routine monitoring of certain cycles of the V-PRO 1, 1 Plus, maX, maX2, 60, s2 Low Temperature Sterilization Systems, STERRAD 100S Sterilizer, STERRAD NX with or without ALLCLEAR, STERRAD 100NX with or without ALLCLEAR and when used in conjunction with the Celerity Incubator, the incubator provides a fluorescent result within 5 minutes.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• 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
13732	Biological sterilization indicator	A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00724995215927	GS1
Primary	10724995215924	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K223717	000