FDA.reportPublic FDA data

Cadwell

Primary DI
00840067103357
Brand
Cadwell
Company
CADWELL INDUSTRIES, INC.
Model
302556-200-0080
Device description
Snore Microphone
Published
2021-12-15
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
BZQMonitor, breathing frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941759000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941759000SNORING SENSOREpm Development Systems Corp.1994-11-10BZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067103357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067103357008400671033578400671033570840067103357

GMDN Terms#

Term, Definition table
TermDefinition
Home-use sleep apnoea recording systemA battery-powered device intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort, airflow waveform) during sleep in the home, to facilitate the diagnosis of sleep apnoea. It typically consists of multiple components including a control unit which may have some user-interface functionality, sensors, and connecting leads, which record parameters and may upload the data to a central analysis system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length200Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
098554157
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
076401218816261ST272-100 LuMon™ Belt Size 19SenTec AGBZQ2026-10-26
076401218816331ST273-100 LuMon™ Belt Size 22SenTec AGBZQ2026-10-26
076401218816401ST274-100 LuMon™ Belt Size 26SenTec AGBZQ2026-10-26
076401218816571ST275-100 LuMon™ Belt Size 30SenTec AGBZQ2026-10-26
076401218816641ST276-100 LuMon™ Belt Size 35SenTec AGBZQ2026-10-26
076401218816711ST277-100 LuMon™ Belt Size 40SenTec AGBZQ2026-10-26
076401218816881ST278-100 LuMon™ Belt Size 47SenTec AGBZQ2026-10-26
076401218816951ST282-100 LuMon™ Belt Size 80SenTec AGBZQ2026-10-26
076401218817011ST283-100 LuMon™ Belt Size 92SenTec AGBZQ2026-10-26
076401218817181ST284-100 LuMon™ Belt Size 104SenTec AGBZQ2026-10-26
076401218817251ST285-100 LuMon™ Belt Size 116SenTec AGBZQ2026-10-26
076401218817631ST120-100 LuMon™ Connector 2.0SenTec AGBZQ2026-10-26
076401218817562ST200-100 LuMon™ MonitorSenTec AGBZQ2026-10-23
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyBZQ2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyBZQ2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyBZQ2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyBZQ2026-10-04
89061709200204DOZEETURTLE SHELL TECHNOLOGIES PRIVATE LIMITEDBZQ2026-08-19
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.BZQ2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.BZQ2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.BZQ2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.BZQ2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZQ2026-06-02
20653405024962CONMEDConmed CorporationBZQ2026-03-24
10889483224366MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
10889483225295MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.BZQ2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.BZQ2025-12-10
07640121881053103583 LuMon™ Contact Gel KitSenTec AGBZQ2025-09-08
10889483610565Resmed Sleep Apnealink CannulaSALTER LABSBZQ2025-07-11