Pall® Breathing Circuit Filter

Basic Information

• Brand Name: Pall® Breathing Circuit Filter
• Primary DI: 00636207000248
• Version / Model: BB50T
• Catalog Number: BB50T
• 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: 8
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 22f34cd0-f5ab-41e2-8c73-bf1bb8f355b0

Device Description

Bi-directional bacterial/viral removal filter. Indicated for use on ventilators, water bath humidifiers and other medical gas equipment where the gas outlet fitting complies to ISO 5356-1 for the protection of the patient, staff, equipment and environment. Provides greater than 99.999% bacterial and viral efficiency.

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
61135	Microbial medical gas filter, reusable	A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00636207000248	GS1
Package	30636207000249	GS1	case	50	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K791307	000

Device Sizes

Type	Value	Unit	Text
Total Volume	90	Milliliter
Device Size Text, specify			>99.999% bacterial/viral efficiency