FDA.reportPublic FDA data

ARES 610 Unicorder System

Primary DI
00854485007098
Brand
ARES 610 Unicorder System
Company
Watermark Medical, Inc.
Model
610
Catalog number
WMU 1610-001
Device description
ARES 610 HST Recorder and disposables
Published
2017-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNSTIMULATOR, NERVE
MNRVENTILATORY EFFORT RECORDER
NFBConserver, oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
MNRVentilatory Effort RecorderAnesthesiology2
NFBConserver, OxygenAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110705000
K111194000
K112514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110705000APNEA RISK EVALUATION SYSTEM (ARES)Advanced Brain Monitoring, Inc.2011-04-14MNR
K111194000APNEA RISK EVALUATION SYSTEM (ARES)Advanced Brain Monitoring, Inc.2011-07-07MNR
K112514000APNEA RISK EVALUATION SYSTEM (ARES)Advanced Brain Monitoring, Inc.2012-01-09MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854485007098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854485007098008544850070988544850070980854485007098

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous electrodeA non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature15 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)710-6999Qualitycontrol@sleepmedinc.com

Regulatory Flags#

DUNS number
017159127
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854485007012ARES 620 Unicorder System620W012192017-05-19
00854485007036ARES 620 Home Sleep Test Accessories - 10 pack620W036212017-05-19
00854485007043ARES620 Secure Sleep Test Accessories - 10 pack620W043222017-05-19
00854485007104ARES 610 Home Sleep Test Accessories - 10 pack610WMDK-0012017-05-19
00854485007111ARES 610 Home Sleep Test Accessories - 50 Pack610WM 10062017-05-19
00854485007005ARES 620 Unicorder620W005172017-05-19
00854485007050ARES620 Respiration Module Assembly620W050232017-05-19
00854485007067ARES620 Respiration Adapter Assembly620W067242017-05-19
00854485007074ARES620 Respiration Belt Assembly620W074252017-05-19
00854485007081ARES 610 Unicorder610WM16032017-05-19
00854485007128ARES Secure Sleep Study Accessories610/620WM 10032017-05-19
00854485007135ARES Secure Sleep Study Disposable Kit - 10 pack610/620WM-10042017-05-19
00854485007142ARES COC Cable610/620W142052017-05-19
00854485007159ARES COC Dongle610/620W159062017-05-19
00854485007166ARES620 Respiration Adapter Cable620W166262017-05-19
00854485007173ARES 620 Respiration Effort System620W173272017-08-07
00854485007180ARES 620 Respiration Effort Disposables Kit - 10 pack620W180282017-08-07
00854485007197ARES Nasal Cannula1130W197292021-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000821777NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821784NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821791NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821807NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821814NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15
08720256698340Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.MNR2026-05-15
08720256698364Onera STS 2Onera B.V.MNR2026-05-15
08720256698371Onera STS 2Onera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.MNR2026-05-15
08720256698487Onera STSOnera B.V.MNR2026-05-15
08720256698494Onera STSOnera B.V.MNR2026-05-15
08720256698500Onera STSOnera B.V.MNR2026-05-15
08720256698517Onera STSOnera B.V.MNR2026-05-15
08720256698524Onera STSOnera B.V.MNR2026-05-15
08720256698531Onera STSOnera B.V.MNR2026-05-15
08885021950044TipTraQPRANAQ PTE. LTD.MNR2026-05-15
08885021950051TipTraQPRANAQ PTE. LTD.MNR2026-05-11
09342451002785Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
20199150023862N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023879N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023886N/AMEDTRONIC XOMED, INC.ETN2026-02-16