AccessGUDID - DEVICE: A9800 Anesthesia Workstation (00815085020061)

GUDID

Device Identifier (DI) Information

Brand Name: A9800 Anesthesia Workstation
Version or Model: A9800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0081508502006
Company Name: ORICARE INC.

Primary DI Number: 00815085020061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009527042 *Terms of Use

Device Description: Anesthesia Workstation with standard features plus: Side Stream Gas. German Language. Europe Power Setup

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSZ	Gas-Machine, Anesthesia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131790	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3cb27411-7dec-4773-93db-5bbbbb4021cd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 25, 2016