Pulmoguard

Basic Information

• Brand Name: Pulmoguard
• Primary DI: B279F0412050
• Version / Model: II, Kushion Klip, Flotube
• Catalog Number: F0412-050
• Company Name: S D I DIAGNOSTICS INC
• Labeler DUNS: 037690120
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 4
• Public Version Date: 2019-03-27
• Public Version Status: Update
• Public Device Record Key: 192109ba-ac5b-4594-8b82-fdcfdbacc4b1
• Distribution End Date: 2019-03-26

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
Package	B279F0412200	HIBCC	case	50	Not in Commercial Distribution	2019-03-26
Primary	B279F0412050	HIBCC
Unit of Use	B279F04120501	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K934509	000