Spiration Valve System

Basic Information

• Brand Name: Spiration Valve System
• Primary DI: 00896506002316
• Version / Model: SVS-C26N-06
• Company Name: Gyrus Acmi, Inc.
• Labeler DUNS: 117521967
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-29
• Public Version: 2
• Public Version Date: 2021-03-04
• Public Version Status: Update
• Public Device Record Key: c918011e-33b1-439f-950c-c052d152e47d

Device Description

Deployment Catheter and Loader, 2.6

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
NJK	Valve, Pulmonary	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47614	Endobronchial valve delivery catheter	A sterile, long, thin, flexible tube designed to deliver and place a non-surgical implantable endobronchial valve, via the working channel of a bronchoscope, into the bronchial lumen of a lung segment. It typically includes a loader; a tool that is used to compress the endobronchial valve and inserts the valve into the catheter. The catheter may be used to deliver multiple size endobronchial valves in a single-patient procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00896506002316	GS1

Premarket Submissions

Submission Number	Supplement Number
P180007	000