FDA.reportPublic FDA data

Minncare HD

Primary DI
00677964066863
Brand
Minncare HD
Company
MEDIVATORS INC.
Model
3029764
Catalog number
3029764
Device description
Minncare HD (4 x 1 Gallon)
Published
2018-01-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIHDisinfectant, Subsystem, Water Purification

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIHDisinfectant, Subsystem, Water PurificationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133724000MINNCARE HDMedivators, Inc.2014-08-27NIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30677964066864PackageGS14Not in Commercial Distribution
00677964066863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3067796406686430677964066864
00677964066863006779640668636779640668630677964066863

GMDN Terms#

Term, Definition table
TermDefinition
Organic peroxy acid device sterilant, single-useA substance in liquid or powder (reconstituted with water) form that includes an organic peroxy acid (e.g., peracetic acid, perpyruvic acid) as its primary agent intended to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature075 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)444-4729custserv@MEDIVATORS.com

Regulatory Flags#

DUNS number
068199363
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00677964154133Endo Carry-on Procedure Kit401156440115642026-10-28
00677964154140Endo Carry-on Procedure Kit401156540115652026-10-28
00677964154157Endo Carry-on Procedure Kit401156740115672026-10-28
00677964154164Endo Carry-on Procedure Kit401157740115772026-10-28
00677964154171Endo Carry-on Procedure Kit401157840115782026-10-28
00677964154188Endo Carry-on Procedure Kit401169040116902026-10-28
00677964154195Endo Carry-on Procedure Kit401168040116802026-10-28
00677964154201Endo Carry-on Procedure Kit401168240116822026-10-28
00677964154218Endo Carry-on Procedure Kit401168340116832026-10-28
00677964154225Endo Carry-on Procedure Kit401168440116842026-10-28
00677964154232Endo Carry-on Procedure Kit401168540116852026-10-28
00677964154249Endo Carry-on Procedure Kit401168640116862026-10-28
00677964154256Endo Carry-on Procedure Kit401158140115812026-10-28
00677964154263Endo Carry-on Procedure Kit401168140116812026-10-28
00677964154270Endo Carry-on Procedure Kit401169640116962026-10-28
00677964154287Endo Carry-on Procedure Kit401169740116972026-10-28
00677964154294Endo Carry-on Procedure Kit401170240117022026-10-28
00677964154300Endo Carry-on Procedure Kit401170140117012026-10-28
00677964154317Endo Carry-on Procedure Kit401171240117122026-10-28
00677964154324Endo Carry-on Procedure Kit401171340117132026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995223298Minncare HDMEDIVATORS INC.NIH2024-03-26
50724995223293Minncare HDMEDIVATORS INC.NIH2024-03-26
00817724022894LuxisseHEANY INDUSTRIES, INC.NIH2019-11-05
00854001007564SPRINTSPR THERAPEUTICS, INC.NIH2018-09-14
00677964066870Minncare HDMEDIVATORS INC.NIH2018-01-09
00677964079498Minncare HDMEDIVATORS INC.NIH2018-01-09
30677964066888Minncare HD Residual Test StripsMEDIVATORS INC.NIH2018-01-09
30677964066895Minncare HD 1% Indicator Test StripsMEDIVATORS INC.NIH2018-01-09
30677964066864Minncare HDMEDIVATORS INC.NIH2018-01-09
30677964066871Minncare HDMEDIVATORS INC.NIH2018-01-09
30677964079499Minncare HDMEDIVATORS INC.NIH2018-01-09