ARES620 Respiration Module Assembly W05023

GUDID 00854485007050

ARES 620 Bluetooth Module

Watermark Medical, Inc.

Home-use sleep apnoea recording system

• Primary Device ID: 00854485007050
• NIH Device Record Key: 439e1d2a-53da-44f9-b39c-c4dba3026d64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARES620 Respiration Module Assembly
• Version Model Number: 620
• Catalog Number: W05023
• Company DUNS: 017159127
• Company Name: Watermark Medical, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com
• Phone: +1(877)710-6999
• Email: Qualitycontrol@sleepmedinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854485007050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160499

FDA Product Code

• MNR: VENTILATORY EFFORT RECORDER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-19

Devices Manufactured by Watermark Medical, Inc.

• 00854485007197 - ARES Nasal Cannula: 2021-03-02 ARES Nasal Cannula
• 00854485007005 - ARES 620 Unicorder: 2018-07-06 ARES 620 HST Recorder
• 00854485007012 - ARES 620 Unicorder System: 2018-07-06 ARES 620 HST Recorder and Disposables
• 00854485007036 - ARES 620 Home Sleep Test Accessories - 10 pack: 2018-07-06 ARES 620 HST Disposables (non-CoC) x10
• 00854485007043 - ARES620 Secure Sleep Test Accessories - 10 pack: 2018-07-06 ARES 620 CoC Disposables - (all disposables plus CoC shield) x10
• 00854485007050 - ARES620 Respiration Module Assembly: 2018-07-06ARES 620 Bluetooth Module
• 00854485007050 - ARES620 Respiration Module Assembly: 2018-07-06 ARES 620 Bluetooth Module
• 00854485007067 - ARES620 Respiration Adapter Assembly: 2018-07-06 ARES 620 Effort Belt Adapter
• 00854485007074 - ARES620 Respiration Belt Assembly: 2018-07-06 ARES 620 Resp Belt Assembly