FDA.reportPublic FDA data

Minncare HD

Primary DI
30677964066864
Brand
Minncare HD
Company
MEDIVATORS INC.
Model
3029764
Published
2018-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
30677964066864PackageGS14In 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
Storage Environment Temperature0 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
068199363
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26
00677964153648Endo Carry-on Procedure Kit401124340112432026-05-26
00677964153655Endo Carry-on Procedure Kit401124440112442026-05-26
00677964153662Endo Carry-on Procedure Kit401124540112452026-05-26
00677964153679Endo Carry-on Procedure Kit401121440112142026-05-26
00677964153686Endo Carry-on Procedure Kit401123640112362026-05-26
00677964153693Endo Carry-on Procedure Kit401123740112372026-05-26
00677964153709Endo Carry-on Procedure Kit401123840112382026-05-26
00677964153716Endo Carry-on Procedure Kit401125040112502026-05-26
00677964153723Endo Carry-on Procedure Kit401125240112522026-05-26
00677964153730Endo Carry-on Procedure Kit401123940112392026-05-26
00677964153747Endo Carry-on Procedure Kit401125140112512026-05-26
00677964153754Endo Carry-on Procedure Kit401125340112532026-05-26
00677964153761Endo Carry-on Procedure Kit401125440112542026-05-26
00677964153778Endo Carry-on Procedure Kit401136040113602026-05-26
00677964153785Endo Carry-on Procedure Kit401136140113612026-05-26
00677964057281Endo Carry-On Procedure Kit1008491008492018-06-22
00677964153488Endo Carry-on Procedure Kit401119340111932026-04-29

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
00677964066863Minncare HDMEDIVATORS INC.NIH2018-01-09
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
30677964066871Minncare HDMEDIVATORS INC.NIH2018-01-09
30677964079499Minncare HDMEDIVATORS INC.NIH2018-01-09