FDA.reportPublic FDA data

ARES 620 Unicorder System

Primary DI
00854485007012
Brand
ARES 620 Unicorder System
Company
Watermark Medical, Inc.
Model
620
Catalog number
W01219
Device description
ARES 620 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
K160499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160499000Apnea Risk Evaluation System (ARES), Model 620Watermark Medical2017-04-24MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854485007012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854485007012008544850070128544850070120854485007012

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
00854485007036ARES 620 Home Sleep Test Accessories - 10 pack620W036212017-05-19
00854485007043ARES620 Secure Sleep Test Accessories - 10 pack620W043222017-05-19
00854485007098ARES 610 Unicorder System610WMU 1610-0012017-05-19
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

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Primary DI, Brand, Company table
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00810161901555EARP NERVE CUFF ELECTRODE, 4MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
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