Alleset

Basic Information

• Brand Name: Alleset
• Primary DI: 16931918155692
• Version / Model: Model C-2003-NS
• Company Name: GRI Medical & Electronic Technology Co., Ltd.
• Labeler DUNS: 679894738
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2021-03-08
• Public Version: 1
• Public Version Date: 2021-03-16
• Public Version Status: New
• Public Device Record Key: 374c6ef0-6c43-4a75-8884-8baf6e02cb27

Device Description

Insufflation Tubing 10ft (3m) with 0.1-micron Hi-Flow Filter, Push-On Fitting,Non-Sterile_100ea/cs

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
38559	Insufflation gas conditioning tubing set	A collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26931918155699	GS1	carton	2	In Commercial Distribution
Primary	16931918155692	GS1
Unit of Use	06931918155695	GS1

Customer Contacts

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