Celerity

Basic Information

• Brand Name: Celerity
• Primary DI: 10724995167759
• Version / Model: LCB054
• Catalog Number: LCB054
• Company Name: STERIS CORPORATION
• Labeler DUNS: 961394798
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2019-07-19
• Public Version: 2
• Public Version Date: 2020-11-03
• Public Version Status: Update
• Public Device Record Key: 0d8cf7e6-c6a3-4545-8a8a-c90c18124b23

Device Description

The Celerity Xtend 10 Assembly with a Celerity 20 STEAM Biological Indicator and a Celerity 10 STEAM Chemical Indicator can be used for routine monitoring of 10-Minute 270 degrees F/132 degrees C dynamic air removal steam sterilization cycles. The sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

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: No
• Has Lot/Batch Number: Yes
• 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
Primary	10724995167759	GS1
Unit of Use	00724995167752	GS1

Customer Contacts

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