HarmonyAIR QS0028

GUDID 00724995150129

The HarmonyAIR Smoke Evacuator Remote Switch Activator (RSA) is used with the HarmonyAIR Smoke Evacuation System.

STERIS CORPORATION

Surgical plume evacuation system

• Primary Device ID: 00724995150129
• NIH Device Record Key: f6fabbb8-cb24-4596-93e4-6ed3241c8bd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HarmonyAIR
• Version Model Number: Smoke Evacuator Remote Switch Activator
• Catalog Number: QS0028
• Company DUNS: 036985604
• Company Name: STERIS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995150129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131402

FDA Product Code

• FYD: APPARATUS, EXHAUST, SURGICAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2016-09-06

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• 50724995150087: The HarmonyAIR Sterile Smoke Evacuator Tubing, 7/8 inch x 10 foot sterile tubing, is used for th
• 50724995150070: The HarmonyAIR Sterile Smoke Evacuator Tubing, 7/8 inch x 6 foot sterile tubing, is used for the
• 50724995150063: The HarmonyAIR Smoke Evacuator Filters are 1/4", 3/8" and 7/8" ports that are used with HarmonyA
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• 00724995176433: E-Series Dual Light with CP, No Drop Tube, No Camera, Tandem is a ceiling supported surgical li
• 00724995176426: E-Series Dual Light with CP, 20-inch Drop Tube, No Camera, Tandem is a ceiling supported surgic
• 00724995176419: E-Series Dual Light with CP, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgic
• 00724995176402: E-Series Dual Light with CP, No Drop Tube, Tandem is a ceiling supported surgical lighting syste
• 00724995176396: E-Series Dual Light with CP, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting
• 00724995176389: E-Series Dual Light with CP, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting
• 00724995176372: E-Series Dual Light with CP, No Drop Tube, No Camera is a ceiling supported surgical lighting sy
• 00724995176365: E-Series Dual Light with CP, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighti
• 00724995176358: E-Series Dual Light with CP, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighti
• 00724995176341: E-Series Dual Light with CP, No Drop Tube is a ceiling supported surgical lighting system of on
• 00724995176334: E-Series Dual Light with CP, 20-inch Drop Tube is a ceiling supported surgical lighting system o
• 00724995176327: E-Series Dual Light with CP, 13-inch Drop Tube is a ceiling supported surgical lighting system
• 00724995176310: E-Series High Definition Dual Light with CP, No Drop Tube, No Camera, Tandem is a ceiling suppo
• 00724995176303: E-Series High Definition Dual Light with CP, 20-inch Drop Tube, No Camera, Tandem is a ceiling
• 00724995176297: E-Series High Definition Dual Light with CP, 13-inch Drop Tube, No Camera, Tandem is a ceiling
• 00724995176280: E-Series High Definition Dual Light with CP, No Drop Tube, Tandem is a ceiling supported surgic
• 00724995176273: E-Series High Definition Dual Light with CP, 20-inch Drop Tube, Tandem is a ceiling supported su
• 00724995176266: E-Series High Definition Dual Light with CP, 13-inch Drop Tube, Tandem is a ceiling supported s
• 00724995176259: E-Series High Definition Dual Light with CP, No Drop Tube, No Camera is a ceiling supported surg
• 00724995176242: E-Series High Definition Dual Light with CP, 20-inch Drop Tube, No Camera is a ceiling supported
• 00724995176235: E-Series High Definition Dual Light with CP, 13-inch Drop Tube, No Camera is a ceiling supported
• 00724995176228: E-Series High Definition Dual Light with CP, No Drop Tube is a ceiling supported surgical lighti
• 00724995176211: E-Series High Definition Dual Light with CP, 20-inch Drop Tube is a ceiling supported surgical
• 00724995176204: E-Series High Definition Dual Light with CP, 13-inch Drop Tube is a ceiling supported surgical l
• 00724995176198: The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, No Drop Tube, No Camera, Tandem is
• 00724995176181: The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, 20-inch Drop Tube, No Camera, Tandem
• 00724995176174: The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, 13-inch Drop Tube, No Camera, Tandem
• 00724995176167: The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, No Drop Tube, No Camera is a ceiling
• 00724995176150: The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, 20-inch Drop Tube, No Camera is a ce
• 00724995176143: The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, 13-inch Drop Tube, No Camera is a ce
• 00724995176136: E-Series Hybrid High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Cam
• 00724995176129: E-Series Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, N
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• 00724995176105: E-Series Hybrid High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem
• 00724995176099: E-Series Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, T
• 00724995176082: E-Series Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, T
• 00724995176075: E-Series Hybrid High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Cam
• 00724995176068: E-Series Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, N
• 00724995176051: E-Series Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, N