Pulmonary Filtration Technologies

Basic Information

• Brand Name: Pulmonary Filtration Technologies
• Primary DI: 10868750000230
• Version / Model: 7600PFT
• Catalog Number: 7600PFT
• Company Name: WHITE CARDIOPULMONARY, INC.
• Labeler DUNS: 058027090
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2019-05-27
• Public Version Status: Update
• Public Device Record Key: abb240cb-e4f6-4957-9c31-9f17ef129b0b
• Distribution End Date: 2019-05-16

Device Description

10868750000230 = basePkg; 20868750000237 = higherPkg1 - contains 100 of the base package Primary DI inside it; 30868750000234 = higherPkg2 - contains 4 of the higherPkg1 inside it. Disposable bacterial/viral filter for pulmonary function testing - green

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: Yes
• 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
Primary	10868750000230	GS1