Ultipor™ Anesthesia Breathing Circuit System - Patient Kit

Basic Information

• Brand Name: Ultipor™ Anesthesia Breathing Circuit System - Patient Kit
• Primary DI: 00636207315298
• Version / Model: VMPKSA
• Catalog Number: VMPKSA
• 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: 2016-06-29
• Public Version: 4
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 1e9e2bab-e826-4e7f-bffa-87bf50ff6899

Device Description

Small Vanilla-Scented Adult Face Mask, Ported Elbow and Ultipor 25 Filter. Non-Conductive, Disposable.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
CAH	Filter, bacterial, breathing-circuit	Anesthesiology	868.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62128	Patient-end respiratory anaesthesia kit	A collection of non-sterile devices intended to create a hygienic connection between a patient’s airway and an anaesthesia breathing circuit. It is primarily intended for use with a reusable breathing circuit and typically includes an anaesthesia mask, a tube/mask breathing circuit connector and a microbial medical gas filter. This is a single-patient reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30636207315299	GS1	case	20	In Commercial Distribution
Primary	00636207315298	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K013093	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%.