ARES 620 Home Sleep Test Accessories - 10 pack W03621

GUDID 00854485007036

ARES 620 HST Disposables (non-CoC) x10

Watermark Medical, Inc.

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• Primary Device ID: 00854485007036
• NIH Device Record Key: eae9e102-8f6e-4e21-8b72-d3140123f2f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARES 620 Home Sleep Test Accessories - 10 pack
• Version Model Number: 620
• Catalog Number: W03621
• 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: true
• 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: 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
• 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
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854485007036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160499

FDA Product Code

• NFB: Conserver, oxygen

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.

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• 00854485007012 - ARES 620 Unicorder System: 2018-07-06 ARES 620 HST Recorder and Disposables
• 00854485007036 - ARES 620 Home Sleep Test Accessories - 10 pack: 2018-07-06ARES 620 HST Disposables (non-CoC) x10
• 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: 2018-07-06 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