Sovant

Basic Information

• Brand Name: Sovant
• Primary DI: 00858545007028
• Version / Model: SV1000
• Company Name: DYNASTHETICS, LLC
• Labeler DUNS: 042681859
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-24
• Public Version: 1
• Public Version Date: 2024-10-02
• Public Version Status: New
• Public Device Record Key: 1d0cedf9-0a99-46ed-a779-d8f1036c1ebb

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
Primary	00858545007028	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092031	000