Celerity

Basic Information

• Brand Name: Celerity
• Primary DI: 10724995218581
• Version / Model: PCC079
• Catalog Number: PCC079
• Company Name: ALBERT BROWNE LIMITED
• Labeler DUNS: 218172765
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2022-08-10
• Public Version: 4
• Public Version Date: 2024-02-27
• Public Version Status: Update
• Public Device Record Key: 03f6286a-95e8-4b41-be4a-a36c292786db

Device Description

Celerity HP Multivariable CI is designed for routine monitoring of Lumen, Non-Lumen, Flexible, Fast Non Lumen, Fast sterilization cycle of a V-PRO Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD System, including those systems with ALLClear Technology.

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
QKM	A chemical vapor sterilization multivariable chemical indicator	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995218589	GS1	Case	40	In Commercial Distribution
Primary	10724995218581	GS1
Unit of Use	00724995218584	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K213262	000
K231488	000