FDA.reportPublic FDA data

CER-2

Primary DI
00677964021725
Brand
CER-2
Company
MEDIVATORS INC.
Model
CER-2
Catalog number
78399726
Device description
CER-2
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVEWasher, Cleaner, Automated, Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVEWasher, Cleaner, Automated, EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K871712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K871712000MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.Machida America, Inc.1988-01-14NVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00677964021725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00677964021725006779640217256779640217250677964021725

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope washer/disinfectorA mains electricity (AC-powered) unit intended to be used for the washing and/or disinfecting of endoscopes with water or an appropriate disinfectant solution. It has built-in features to circulate a solution through the lumen (flushing) of the endoscope; some types may also have built-in drying features.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873custserv@medivators.com

Regulatory Flags#

DUNS number
068199363
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995229641DEFENDO400805540080552024-03-25
00677964021695CER-1CER-178399-7232016-09-20
00677964033858DSD-201DSD-201 120VDSD20172016-09-20
00677964035647SSD-102SSD-102SSD20072016-09-20
00677964044755Advantage Plus Endoscope Reprocessing System1-2-510.0032016-09-16
00677964046674DSD Edge Endoscope Reprocessing SystemDSD Edge 120VDSD30082016-09-16
00677964052484CER-1 OptimaCER-1 OptimaCER1OPTIMA2016-09-20
00677964052491CER-2 OptimaCER-2 OptimaCER2OPTIMA2016-09-20
00677964095832Advantage Plus Pass-Thru1-2-610.003126100032018-02-06
00677964153877Endo Carry-on Procedure Kit401137340113732026-07-20
00677964153921Endo Carry-on Procedure Kit401139040113902026-07-20
00677964153976Endo Carry-on Procedure Kit401141240114122026-07-20
00677964154089Endo Carry-on Procedure Kit401144940114492026-07-20
00677964154096Endo Carry-on Procedure Kit401146040114602026-07-20
00677964051555Medivators HookupHookup58112CAS2024-04-01
00677964053450Medivators HookupHookup28338CAS2024-04-01
00677964002328Medivators HookupHookup28718CAS2023-04-10
00677964037856Medivators HookupHookup28612CAS2023-04-10
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00677964072970Medivators HookupMEDIVATORS INC.NVE2024-04-01
00677964089039Medivators HookupMEDIVATORS INC.NVE2024-04-01
00677964089091Medivators HookupMEDIVATORS INC.NVE2024-04-01
00677964089046Medivators HookupMEDIVATORS INC.NVE2023-10-16
00677964033070Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064210Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064227Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064258Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064296Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064302Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064326Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064333Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064340Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064357Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064364Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064371Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085222Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085246Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085253Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085260Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085277Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085284Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085291Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088957Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088964Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088971Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088988Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088995Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964089008Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964089015Medivators HookupMEDIVATORS INC.NVE2023-04-10