A9800 Anesthesia Workstation

Basic Information

• Brand Name: A9800 Anesthesia Workstation
• Primary DI: 00815085020177
• Version / Model: A9800
• Catalog Number: 0081508502017
• Company Name: ORICARE INC.
• Labeler DUNS: 009527042
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-25
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 17944367-4f9e-4462-b82a-42b2e25feb01

Device Description

Anesthesia Workstation with standard features only: German Language. Europe Power Setup

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
37710	Anaesthesia workstation, general-purpose	An assembly of electronic devices used for general inhalation anaesthesia (i.e., the delivery of oxygen (O2), nitrous oxide (N2O), other medical gases, and anaesthetic agents) and possibly total intravenous anaesthesia and local anaesthesia. Its main components are high, intermediate, and low pressure gas delivery systems, a breathing circuit (typically with a ventilator), and an anaesthetic gas scavenging system (AGSS). It has built-in alarms, analysers, control/monitoring systems, and typically has integrated circuitry/touchscreen displays for target controlled anaesthesia (TCA) for any type of patient (e.g., neonate, adult).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815085020177	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131790	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal