HarmonyAIR

Basic Information

• Brand Name: HarmonyAIR
• Primary DI: 00724995150099
• Version / Model: Smoke Evacuator Tubing
• Catalog Number: QS0025
• Company Name: STERIS CORPORATION
• Labeler DUNS: 036985604
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 7
• Public Version Date: 2021-01-27
• Public Version Status: Update
• Public Device Record Key: e1aa7b8a-92a7-4591-8fab-63ca3412fe1b
• Distribution End Date: 2020-12-22

Device Description

The HarmonyAIR Sterile Smoke Evacuator Tubing, 7/8 inch x 14 Foot sterile tubing, is used with the HarmonyAIR Smoke Evacuator.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
GAZ	TUBING, NONINVASIVE	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46483	Surgical plume evacuation system tube	A sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995150094	GS1	Box	5	Not in Commercial Distribution	2020-12-22
Primary	00724995150099	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	14	Feet