Vapor Clean

GUDID 80858545007000

Vapor Clean Filter

DYNASTHETICS, LLC

Halogenated vapour absorber

• Primary Device ID: 80858545007000
• NIH Device Record Key: e7f968eb-04c5-40f8-85e0-f2e5ed304a55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vapor Clean
• Version Model Number: 10000
• Company DUNS: 042681859
• Company Name: DYNASTHETICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 801-484-3820
• Email: cservice@dynasthetics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858545007004 [Primary]
GS1	30858545007005 [Package]; Contains: 00858545007004; Package: [3 Units]; In Commercial Distribution
GS1	80858545007000 [Package]; Contains: 00858545007004; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092031

FDA Product Code

• CBN: Apparatus, Gas-Scavenging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-14

On-Brand Devices [Vapor Clean]

• 80858545007017: Vapor Clean Filter
• 80858545007000: Vapor Clean Filter