FDA.reportPublic FDA data

Cadwell

Primary DI
00840067103999
Brand
Cadwell
Company
CADWELL INDUSTRIES, INC.
Model
197342-000
Device description
Disposable Foam, Glow Goggles, 10 pk
Published
2024-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
ETNSTIMULATOR, NERVE
GWEStimulator, photic, evoked response
GWFStimulator, electrical, evoked response
GWJSTIMULATOR, AUDITORY, EVOKED RESPONSE
GWQFull-montage Standard Electroencephalograph
GZODevice, galvanic skin response measurement
IKNElectromyograph, diagnostic
JXEDEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT
OLTNon-normalizing quantitative electroencephalograph software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
ETNStimulator, NerveEar, Nose, Throat2
GWEStimulator, Photic, Evoked ResponseNeurology2
GWFStimulator, Electrical, Evoked ResponseNeurology2
GWJStimulator, Auditory, Evoked ResponseNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
GZODevice, Galvanic Skin Response MeasurementNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
JXEDevice, Nerve Conduction Velocity MeasurementNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067103999PrimaryGS10
10840067103996Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067103999008400671039998400671039990840067103999
1084006710399610840067103996

GMDN Terms#

Term, Definition table
TermDefinition
Neurophysiologic monitoring systemAn assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.

Contacts#

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

Regulatory Flags#

DUNS number
098554157
Device count
10
DM exempt
true
Lot or batch
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
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320387MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320479MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320691MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19
08052990320707MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19
08056446900338NeMus 2 600EB NEURO SPAGWF2025-05-26
08056446900338NeMus 2 600EB NEURO SPAGWE2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWE2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWE2025-05-26
08056446901038GOGGLES STIMULATOR IIEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWF2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAIKN2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWF2025-05-22
08056446901113NExT-PADEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAIKN2025-05-22
08056446901113NExT-PADEB NEURO SPAGWE2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWF2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAIKN2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWE2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAOLT2025-05-22