FDA.reportPublic FDA data

EasyNet

Primary DI
00840067100479
Brand
EasyNet
Company
CADWELL INDUSTRIES, INC.
Model
190208-200
Device description
EasyNet Movement
Published
2016-09-05
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
LELDEVICE, SLEEP ASSESSMENT
MNRVENTILATORY EFFORT RECORDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LELDevice, Sleep AssessmentNeurology2
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040986000CADWELL LIMB MOVEMENT MODULECadwell Laboratories, Inc.2004-07-01LEL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067100479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067100479008400671004798400671004790840067100479

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)245-3001service@cadwell.com
+1(509)735-6481applications@cadwell.com

Regulatory Flags#

DUNS number
098554157
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840067102176Cadwell Patch Electrode with Snap Connector302699-2002018-11-28
00840067102183Cadwell Patch Electrode with Snap Connector302698-2002018-11-28
00840067102206Cadwell Patch Electrode with Snap Connector302696-2002018-11-29
00840067102497Cadwell Patch Electrode with Snap Connector302696-0002017-12-22
00840067104224Cadwell190306-200-COR2026-03-02
00840067104200Cadwell190306-200-TST2026-03-01
00840067104217Cadwell190306-200-LEG2026-03-01
00840067102954Cadwell302767-2002024-06-30
00840067103944Cadwell302553-200-00002022-03-15
00840067103364Cadwell302556-200-90802021-12-15
00840067103722Cadwell302515-200-04802021-12-15
00840067103746Cadwell302516-200-02802021-12-15
00840067102503ApneaTrak190306-2002019-04-15
00840067104149Cadwell BlueBird302501-200-0302025-12-31
00840067104163Cadwell BlueBird302501-200-0402025-12-31
00840067104187Cadwell BlueBird302501-200-0502025-12-31
00840067102305Cadwell Bar302146-2002025-12-31
00840067103005Cadwell302692-2002025-12-31
00840067103029Zenith199355-2002025-12-31
00840067104132Cadwell BlueBird302501-200-0302025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250413407392Sensor kit for SOMNOscreen (paediatric)SOMNOmedics AGMNR2026-10-10
04250413407408Sensor kit for SOMNOscreen (extra small)SOMNOmedics AGMNR2026-10-10
04250413402380Pneumatic Effort Belt - Size XSSOMNOmedics AGMNR2026-10-09
04250413402397Pneumatic Effort Belt - Size SSOMNOmedics AGMNR2026-10-09
04250413402403Pneumatic Effort Belt - Size MSOMNOmedics AGMNR2026-10-09
04250413402410Pneumatic Effort Belt - Size LSOMNOmedics AGMNR2026-10-09
04250413402427Pneumatic Effort Belt - Size XXLSOMNOmedics AGMNR2026-10-09
04250413410392Wireless PLM/EMG sensor right legSOMNOmedics AGMNR2026-10-08
04250413401635DOMINO lightSOMNOmedics AGMNR2026-10-07
04250413402861EEG-ElectrodeSOMNOmedics AGMNR2026-10-07
04250413404858SOMNOtouch™ RESP ecoSOMNOmedics AGMNR2026-10-07
04250413405664DOMINOSOMNOmedics AGMNR2026-10-07
04250413410385Wireless PLM/EMG sensor left legSOMNOmedics AGMNR2026-10-07
00850063034395Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034500Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034517Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00860000272421Rhythm ExpressVIVAQUANT, INC.MNR2026-10-01
08885021950075TipTraQPRANAQ PTE. LTD.MNR2026-09-25
08885021950105TipTraQPRANAQ PTE. LTD.MNR2026-09-25
04250413410637SOMNOscreen HDSOMNOmedics AGMNR2026-08-13
04250413406388SOMNOwatch™ eco orangeSOMNOmedics AGMNR2026-07-07
04250413405725HomeSleepTestSOMNOmedics AGMNR2026-07-02
04250413405732HomeSleepTest REM+SOMNOmedics AGMNR2026-07-02
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