FDA.reportPublic FDA data

Cadwell

Primary DI
00840067104217
Brand
Cadwell
Company
CADWELL INDUSTRIES, INC.
Model
190306-200-LEG
Device description
ApneaTrak
Published
2026-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNRVentilatory effort recorder
OLVStandard polysomnograph with electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192624000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192624000ApneaTrakCadwell Industries, Inc.2020-02-20OLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067104217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067104217008400671042178400671042170840067104217

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
098554157
Device count
1
DM exempt
true
Serial number
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
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
00840067104156Cadwell BlueBird302501-200-0402025-12-31

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 AGOLV2026-10-07
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
00850063034401Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034418Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034425Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034432Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034449Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034456Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034470Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034487Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034494Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034524Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
08885021950075TipTraQPRANAQ PTE. LTD.MNR2026-09-25
08885021950105TipTraQPRANAQ PTE. LTD.MNR2026-09-25