AIRSEAL

Basic Information

• Brand Name: AIRSEAL
• Primary DI: 10851885004013
• Version / Model: SEM-EVAC
• Catalog Number: SEM-EVAC
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: 6700b7a7-68f5-44c9-b68e-9d2c14a18381

Device Description

AIRSEAL BIFURCATED SMOKE EVAC FILTERED SUBE SET

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: No
• 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: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIF	INSUFFLATOR, LAPAROSCOPIC	Obstetrics/Gynecology	884.1730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60738	Endoscopic insufflation tubing set, single-use	A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30851885004017	GS1	BOX	6	In Commercial Distribution
Primary	10851885004013	GS1
Unit of Use	00851885004016	GS1

Customer Contacts

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