ANEclear 90020

GUDID 10863034000326

Anesthesia Recovery Device

ANECARE, LLC

Anaesthesia workstation gas scavenger

• Primary Device ID: 10863034000326
• NIH Device Record Key: f3124d40-d5cd-48f9-bb4c-6ce48fa33cea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANEclear
• Version Model Number: 2
• Catalog Number: 90020
• Company DUNS: 824640226
• Company Name: ANECARE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 801-977-8877
• Email: sslatter@anecare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863034000329 [Primary]
GS1	10863034000326 [Package]; Contains: 00863034000329; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033028

FDA Product Code

• BYW: Device, Rebreathing

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-27