AeroClear

Basic Information

• Brand Name: AeroClear
• Primary DI: 00858439001774
• Version / Model: 9770013
• Company Name: HEMOSTASIS, LLC
• Labeler DUNS: 801380697
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-30
• Public Version: 1
• Public Version Date: 2020-12-08
• Public Version Status: New
• Public Device Record Key: 8b5b5875-3ea0-416a-ba16-e74acde5e25d

Device Description

The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. Inserted on this tubing is a yellow foam seal and a black positioning ring that can both slide along the tubing. A spare larger foam seal and a male connector are also supplied. When surgery is performed in one nasal cavity, the AeroClear is placed in the contralateral cavity and connected to facility suction.

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: Yes
• 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
JOL	Catheter And Tip, Suction	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35917	Surgical/emergency suction cannula, non-illuminating, single-use	An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858439001774	GS1
Package	00858439001781	GS1	Carton	10	In Commercial Distribution
Package	00858439001798	GS1	Carton	2	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature.