FDA.report

QUEX-ED

Primary DI
05990804321003
Brand
QUEX-ED
Company
QX WORLD LTD
Model
NA
Device description
Biofeedback device with software
Published
2021-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HCCDevice, Biofeedback

Product Code Classifications

CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05990804321003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05990804321003059908043210035990804321003

GMDN Terms

TermDefinition
Biofeedback system application softwareAn application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods

Method

Regulatory Flags

DUNS number
401560903
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05999860882015QUEX-EDNA2021-07-08

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