Insufflation filter / tubing set with 22mm filter

Basic Information

• Brand Name: Insufflation filter / tubing set with 22mm filter
• Primary DI: 05051223004127
• Version / Model: PS3605
• Catalog Number: PS3605
• Company Name: PURPLE SURGICAL INTERNATIONAL LIMITED
• Labeler DUNS: 239403863
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: e79462c8-f681-445c-ba37-6d5f0b4a118e

Device Description

The Insufflation filter / tubing set effectively prevents cross contamination between the patient & insufflator.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	884.1730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60839	Microbial medical gas filter, sterile, single-use	A sterile screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia, and/or surgical intervention (e.g., insufflation); it has no additional non-filtering intended uses. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	35051223004128	GS1	shipping carton	25	In Commercial Distribution
Primary	05051223004127	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]