A9800 Anesthesia Workstation 0081508502001

GUDID 00815085020016

Anesthesia Workstation with standard features to include: Side Stream Gas. Chinese Language. China Power Setup

ORICARE INC.

Anaesthesia workstation, general-purpose

• Primary Device ID: 00815085020016
• NIH Device Record Key: d16cd97e-4a2b-4bec-b486-904c7801c41b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A9800 Anesthesia Workstation
• Version Model Number: A9800
• Catalog Number: 0081508502001
• Company DUNS: 009527042
• Company Name: ORICARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815085020016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131790

FDA Product Code

• BSZ: Gas-Machine, Anesthesia

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00815085020016]

Moist Heat or Steam Sterilization

[00815085020016]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-25

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