FDA.reportPublic FDA data

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M445890151O&P Collection Vials C&S/Clean Kits890-15890-152020-08-31
M445891051O&P Collection Vials SAF / Clean/ C&S Kits891-05891-052020-08-31
M445891101Unifix / Clean / C&S Kits O&P Collection Vials891-10891-102020-08-31
M445891171Total-Fix / C&S / Clean O&P Collection Kits891-17891-172020-08-31
M44589117ORNGE1Total-Fix / C&S / Clean O&P Collection Kits891-17_ORNGE891-17_ORNGE2020-08-31
M445891201Formalin / C&S / Clean Stool Collection Kits891-20891-202020-08-31
M445892021Total-Fix / Formalin / C&S / Clean O&P Collection Kits892-02892-022020-08-31
M445892031Z-PVA / Formalin / C&S / Clean O&P Collection Kits892-03892-032020-08-31
M445892030Z-PVA / Formalin / C&S / Clean O&P Collection Kits892-03892-032020-08-31
M4454505K1Bone Marrow Kit4505K4505K2020-09-09
M445891081O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection Kit891-08891-082020-08-31
M445693A50PACK1SED-CONNECT693A 50 PACK693A 50 PACK2016-09-20
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
M445695A1PARA-SED695A695A2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
00840456201060JMUJMU DENTAL, INCJOJ2026-06-05
00840456201077JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCJOJ2026-06-05
00840456201282JMUJMU DENTAL, INCJOJ2026-06-05
00840456201299JMUJMU DENTAL, INCJOJ2026-06-05
00840456201305JMUJMU DENTAL, INCJOJ2026-06-05
00840456201312JMUJMU DENTAL, INCJOJ2026-06-05
00840456201831JMUJMU DENTAL, INCJOJ2026-06-05
00840456201848JMUJMU DENTAL, INCJOJ2026-06-05
00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
00840456201879JMUJMU DENTAL, INCJOJ2026-06-05
00840456201886JMUJMU DENTAL, INCJOJ2026-06-05
00840456201893JMUJMU DENTAL, INCJOJ2026-06-05
00840456201909JMUJMU DENTAL, INCJOJ2026-06-05
00840456201916JMUJMU DENTAL, INCJOJ2026-06-05
00840456201923JMUJMU DENTAL, INCJOJ2026-06-05
00840456201930JMUJMU DENTAL, INCJOJ2026-06-05
00840456201947JMUJMU DENTAL, INCJOJ2026-06-05
00840456202951JMUJMU DENTAL, INCJOJ2026-06-05
00840456202968JMUJMU DENTAL, INCJOJ2026-06-05
00840456202975JMUJMU DENTAL, INCJOJ2026-06-05
00840456202982JMUJMU DENTAL, INCJOJ2026-06-05
00840456202999JMUJMU DENTAL, INCJOJ2026-06-05
00840456207208JMUJMU DENTAL, INCJOJ2026-06-05
00840456207215JMUJMU DENTAL, INCJOJ2026-06-05
00840456215180JMUJMU DENTAL, INCJOJ2026-06-05
00840456215197JMUJMU DENTAL, INCJOJ2026-06-05
00840456215203JMUJMU DENTAL, INCJOJ2026-06-05