CELERITY

Basic Information

• Brand Name: CELERITY
• Primary DI: 00884908114423
• Version / Model: MRLCA000
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-15
• Public Version: 5
• Public Version Date: 2019-10-24
• Public Version Status: Update
• Public Device Record Key: f8d647d4-fb72-4b57-a94a-d6d7374e7d4b
• Distribution End Date: 2019-10-03

Device Description

CELERITY ECG CABLE ACCESSORY PACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJS	Catheter,intravascular,therapeutic,long-term greater than 30 days	General Hospital	880.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36349	Patient monitoring system module, electrocardiographic	A small unit dedicated to the detection, measurement, and recording of the electrical activity of the heart in the form of an electrocardiogram (ECG) obtained through cables/leads connected to the patient. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG parameter/information measured and provided by this module.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50884908114428	GS1	box	25	Not in Commercial Distribution	2019-10-03
Primary	00884908114423	GS1

Customer Contacts

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