AirSeal

Basic Information

• Brand Name: AirSeal
• Primary DI: 10845854051399
• Version / Model: iAS8-dV
• Catalog Number: iAS8-dV
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2021-08-22
• Public Version: 1
• Public Version Date: 2021-08-30
• Public Version Status: New
• Public Device Record Key: 17faed25-ac26-4170-b855-f168dae7429f

Device Description

AirSeal 8mm Cannula Cap and Obtuator with Bladeless Optical Tip, Standard Length

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
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42412	Laparoscopic access cannula, single-use	A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20845854051396	GS1	CASE	1	In Commercial Distribution
Primary	10845854051399	GS1
Unit of Use	00845854051392	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K211104	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius