FDA.reportPublic FDA data

ARES620 Secure Sleep Test Accessories - 10 pack

Primary DI
00854485007043
Brand
ARES620 Secure Sleep Test Accessories - 10 pack
Company
Watermark Medical, Inc.
Model
620
Catalog number
W04322
Device description
ARES 620 CoC Disposables - (all disposables plus CoC shield) x10
Published
2017-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNSTIMULATOR, NERVE
NFBConserver, oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
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
00854485007043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854485007043008544850070438544850070430854485007043

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cleaning wipe, sterileA sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

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
Kit
true
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
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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