FDA.reportPublic FDA data

GERMITEC

Primary DI
03701372800003
Brand
GERMITEC
Company
GERMITEC
Model
AS1V2
Catalog number
AS1V2
Device description
UV-C Disinfection chamber
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
SCSUltraviolet Radiation Disinfection Chamber Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCSUltraviolet Radiation Disinfection Chamber DeviceGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230067000Chronos®Germitec2024-08-28SCS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701372800003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701372800003037013728000033701372800003

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet ambient disinfection lightAn electrically-powered light source designed to destroy bacteria and viruses in the air and/or on surfaces by emission of ultraviolet radiation into the surrounding environment. It is a mounted, or self-standing device, consisting of a tubular bulb or a unit containing the light source, and may include automatic motion sensors or timers, but does not include a user control unit or radiometers. This is a reusable device.

Regulatory Flags#

DUNS number
281455498
Device count
1
Serial number
true
Manufacturing date on label
true