| Primary Device ID | 00854485007173 |
| NIH Device Record Key | 6a75e90d-dd80-4fa6-ba97-449a1918170e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARES 620 Respiration Effort System |
| Version Model Number | 620 |
| Catalog Number | W17327 |
| 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 | false |
| 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 |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com | |
| Phone | +1(877)710-6999 |
| Qualitycontrol@sleepmedinc.com |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854485007173 [Primary] |
| MNR | VENTILATORY EFFORT RECORDER |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-07 |
| 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 | 2018-07-06 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 |