Pall Ultipor™ 100 Breathing System Filter

Basic Information

• Brand Name: Pall Ultipor™ 100 Breathing System Filter
• Primary DI: 00636207300690
• Version / Model: BB100APF
• Catalog Number: BB100APF
• Company Name: Global Life Sciences Solutions USA LLC
• Labeler DUNS: 011658242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-01
• Public Version: 5
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: f12d8bd4-5b43-4e5b-8045-b0394003a1b4

Device Description

Ultipor 100 Breathing System Filter with Monitoring Port and Flex Tube. High efficiency bacterial/viral filter and HME for patient end use with mechanical ventilation and circle anesthesia.

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
CAH	Filter, bacterial, breathing-circuit	Anesthesiology	868.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46816	Heat/moisture exchanger/microbial medical gas filter	A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30636207300691	GS1	case	50	In Commercial Distribution
Primary	00636207300690	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K791307	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			99.999% bacterial/viral efficiency