GloTran VHP Plasma Disinfector

Primary DI
00868536000433
Brand
GloTran VHP Plasma Disinfector
Company
You First Services, Inc.
Model
GT35H
Published
2022-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MECDisinfector, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MECDisinfector, Medical DevicesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868536000433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868536000433008685360004338685360004330868536000433

GMDN Terms#

Term, Definition table
TermDefinition
Plasma disinfectorA mains electricity (AC-powered) device designed to disinfect (destroy microorganisms) from medical devices and related products using hydrogen peroxide (H2O2) gas in plasma state; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with a H2O2 gas inlet, a vacuum pump, a radio-frequency generator with electrodes intended to convert the vapour into plasma, and the appropriate controls. It is typically intended to disinfect devices after cleaning of gross debris; it is not intended to wash devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061191200
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Model table
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