Pulmoguard

Basic Information

• Brand Name: Pulmoguard
• Primary DI: B279F0115080
• Version / Model: Comfit Mouthpiece & Kushion Klip
• Catalog Number: F0115-080
• Company Name: S D I DIAGNOSTICS INC
• Labeler DUNS: 037690120
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 80
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 538d496e-cd4a-48f6-9929-f573a11cc769

Device Description

Bacterial Filter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	868.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60506	Pulmonary function testing kit	A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B279F0115080	HIBCC
Unit of Use	B279F01150802	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K934509	000