Vapor Clean

Basic Information

• Brand Name: Vapor Clean
• Primary DI: 00858545007011
• Version / Model: 10000
• Company Name: DYNASTHETICS, LLC
• Labeler DUNS: 042681859
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 036e14e3-02f8-464f-8eb7-8e29fdb344fb

Device Description

Vapor Clean Filter

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: Yes
• MRI Safety: MR Safe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBN	Apparatus, Gas-Scavenging	Anesthesiology	868.5430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36096	Halogenated vapour absorber	A refillable container (e.g., a canister) placed in an anaesthesia unit/workstation breathing circuit for the removal of halogenated vapours. This device is filled with an appropriate absorbent (e.g., activated charcoal) to chemically remove the halogenated vapours. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	80858545007017	GS1		8	In Commercial Distribution
Primary	00858545007011	GS1
Package	30858545007012	GS1		3	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092031	000