Navigator Aesthetic Delivery System

Basic Information

• Brand Name: Navigator Aesthetic Delivery System
• Primary DI: 00851634007015
• Version / Model: NAV-038
• Catalog Number: NAV-038
• Company Name: CARTICEPT MEDICAL, INC.
• Labeler DUNS: 619025609
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-24
• Public Version: 3
• Public Version Date: 2020-03-17
• Public Version Status: Update
• Public Device Record Key: 95ad600f-c0ec-4c39-817d-941da9761bd7
• Distribution End Date: 2017-11-04

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRN	Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57791	Infusion pump cassette	A sterile device designed to be used in conjunction with an infusion pump or a device containing an infusion pump (e.g., a physiology-monitoring sedation system, physiology-monitoring anaesthesia system), for the delivery of an intravenous (IV) medication (e.g., a sedative or anaesthetic) contained within an independent drug vial. The cassette is inserted into the infusion pump and the drug vial is inserted into the cassette; the cassette tubing interfaces with the pump drive mechanism for medication delivery through connection with an infusion administration set. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00851634007022	GS1	Case of 25	25	Not in Commercial Distribution	2017-11-04
Primary	00851634007015	GS1

Customer Contacts

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