ARES620 Respiration Belt Assembly W07425

GUDID 00854485007074

ARES 620 Resp Belt Assembly

Watermark Medical, Inc.

Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system
Primary Device ID00854485007074
NIH Device Record Keye62b62f3-e145-4049-9cd4-d6a607272242
Commercial Distribution StatusIn Commercial Distribution
Brand NameARES620 Respiration Belt Assembly
Version Model Number620
Catalog NumberW07425
Company DUNS017159127
Company NameWatermark Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com
Phone+1(877)710-6999
EmailQualitycontrol@sleepmedinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854485007074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNRVENTILATORY EFFORT RECORDER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-19

Devices Manufactured by Watermark Medical, Inc.

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00854485007036 - ARES 620 Home Sleep Test Accessories - 10 pack2018-07-06 ARES 620 HST Disposables (non-CoC) x10
00854485007043 - ARES620 Secure Sleep Test Accessories - 10 pack2018-07-06 ARES 620 CoC Disposables - (all disposables plus CoC shield) x10
00854485007050 - ARES620 Respiration Module Assembly2018-07-06 ARES 620 Bluetooth Module
00854485007067 - ARES620 Respiration Adapter Assembly2018-07-06 ARES 620 Effort Belt Adapter
00854485007074 - ARES620 Respiration Belt Assembly2018-07-06ARES 620 Resp Belt Assembly
00854485007074 - ARES620 Respiration Belt Assembly2018-07-06 ARES 620 Resp Belt Assembly

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