Integra SP VS02

Basic Information

• Brand Name: Integra SP VS02
• Primary DI: 00815871020060
• Version / Model: 00101T2
• Company Name: Avante
• Labeler DUNS: 178440426
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-22
• Public Version: 4
• Public Version Date: 2021-03-29
• Public Version Status: Update
• Public Device Record Key: cabaa2bc-219b-45f6-887f-d4d0e61a558c

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSZ	Gas-Machine, Anesthesia	Anesthesiology	868.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44469	Anaesthesia unit, portable	A portable, stand-alone, mechanical device designed to continuously or intermittently administer a mixture of gases [e.g., oxygen (O2), ambient air, nitrous oxide (N2O), anaesthetic agents] to provide a patient with an appropriate level of anaesthesia. It delivers gases to the patient from medical gas cylinders and typically includes mechanical gas-delivery devices (e.g., flowmeters and vaporizers), a manual anaesthesia ventilator, and a patient breathing circuit. It will typically be used by the military or in unconventional surgical settings.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815871020060	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K061102	000