FDA.reportPublic FDA data

Cadwell

Primary DI
00840067103272
Brand
Cadwell
Company
CADWELL INDUSTRIES, INC.
Model
302548-200-0280
Device description
Thermocouple, Pediatric
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
K922112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922112000EASYFLOWEpm Information Systems, Inc.1992-12-07BZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067103272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067103272008400671032728400671032720840067103272

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
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
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyBZQ2026-04-15
20653405024962CONMEDConmed CorporationBZQ2026-03-24
10889483224366MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
10889483225295MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
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
00850064210200Sibel Spacelabs Trek Chest PatchSibel Health Inc.BZQ2025-04-02
00850064210002ANNE Chest Sensor KitSibel Health Inc.BZQ2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.BZQ2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.BZQ2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.BZQ2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.BZQ2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.BZQ2025-03-26
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.BZQ2025-03-13
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDBZQ2025-03-05
G2331000000SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000010SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000020SansaTMHuxley Medical, Inc.BZQ2024-10-21
10843997006184Radius VSMMASIMO CORPORATIONBZQ2024-08-19
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZQ2024-06-19
00195278656681Portrait CVAXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278659446Portrait CSSXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278697165PORTRAIT HSWXBGE Healthcare Finland OyBZQ2024-04-30
00195278713193Portrait HUBXBGE Healthcare Finland OyBZQ2024-04-30