FDA.reportPublic FDA data

Cadwell

Primary DI
00840067103074
Brand
Cadwell
Company
CADWELL INDUSTRIES, INC.
Model
199326-200
Device description
Patient Event Switch
Published
2021-03-30
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
IQASYSTEM, ENVIRONMENTAL CONTROL, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067103074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067103074008400671030748400671030740840067103074

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(509)735-6481applications@cadwell.com

Regulatory Flags#

DUNS number
098554157
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
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
00812664020047TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-26
00812664024557TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-21
00812664024779TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-21
00812664024939TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-21
00812664025127TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-19
00812664024700TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024717TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024724TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024731TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024892TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024908TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024915TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664025134TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664025141TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00840828197007GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-08-18
00840828196864GEN4 DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-07-23
00840828196871GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-23
00840828196758GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196789GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196796GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196802GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196819GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196826GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196833GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196840GEN4 DIGITALCURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196666GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-06-09
00840828196673GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-06-09
00840828196475GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196482GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196499GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27