Pall® Pro-Tec Filter for Pulmonary Function Testing

Basic Information

• Brand Name: Pall® Pro-Tec Filter for Pulmonary Function Testing
• Primary DI: 05034480309143
• Version / Model: PF30S
• Catalog Number: PF30S
• Company Name: Pall International Sàrl
• Labeler DUNS: 485050483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e13998ce-22ea-4032-8395-7ec2202cfed7

Device Description

Pulmonary Function Filter for pulmonary function testing

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
BZG	SPIROMETER, DIAGNOSTIC	Anesthesiology	868.1840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61097	Pulmonary function testing filter/mouthpiece	A non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	35034480309144	GS1	case	25	In Commercial Distribution
Primary	05034480309143	GS1

Customer Contacts

• Phone: [phone] ext. 5164843600
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K854062	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			99.9999% crosscontamination reduction efficiency (when used according to the instructions for use)