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Wavicide MEC Indicator

Primary DI
M44503060
Brand
Wavicide MEC Indicator
Company
MEDICAL CHEMICAL CORPORATION
Model
0306-Strips
Catalog number
0306-Strips
Device description
The Wavicide MEC Indicator is a semi-quantitative indicator designed to monitor the glutaraldehyde concentration of Wavicide-01.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924681000GLUTARALDEHYDE MONITORSPymah Corp.1993-11-17JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M44503061PackageHIBCC6In Commercial Distribution
M44503060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glutaraldehyde device disinfectant/sterilant test stripA sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of glutaraldehyde in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
008496861
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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M445693AESEDEA50PACK1SED-CONNECT693A-E SED+EA693A-E SED+EA2016-09-20
M445693AFUNNEL1SED-CONNECT693A-FUNNEL693A-FUNNEL2016-09-20
M445693ASAMPLE1SED-CONNECT693A-Sample693A-Sample2016-09-20
M445694A1MICRO-SED694A694A2016-09-20
M445694AEA1MICRO-SED694A-EA694A-EA2016-09-20
M445694ASAMPLE1MICRO-SED694A-Sample694A-Sample2016-09-20
M445694ATUBEFUNNEL1MICRO-SED694A-TUBE/FUNNEL 1000694A-TUBE/FUNNEL 10002016-09-20
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