ACIST Navvus® Catheter

Basic Information

• Brand Name: ACIST Navvus® Catheter
• Primary DI: 10841716100014
• Version / Model: 014667
• Company Name: ACIST MEDICAL SYSTEMS, INC.
• Labeler DUNS: 926684994
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: cfb695c0-b630-43f5-a2de-c44acb3062bc

Device Description

Navvus Catheter, p/n 701481-003

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
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	870.2870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15071	Catheter-tip transducer, pressure	A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841716100014	GS1
Package	20841716100011	GS1	Inner box	5	In Commercial Distribution
Package	30841716100018	GS1	Shelf box	1	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K132474	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Working Length: 150 Centimeter