FDA.reportPublic FDA data

CER-1

Primary DI
00677964021695
Brand
CER-1
Company
MEDIVATORS INC.
Model
CER-1
Catalog number
78399-723
Device description
CER-1
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00677964021695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00677964021695006779640216956779640216950677964021695

GMDN Terms#

Term, Definition table
TermDefinition
Instrument non-thermal chemical disinfectorAn electrically-powered unit intended to be used for the non-thermal chemical disinfection of probes, surgical instruments, and/or endoscopes, and their accessories (e.g., heat-sensitive instruments). It may include washing features and may have built-in features to circulate cleaning and disinfectant solutions through a device lumen; some types may also have built-in drying features. It is not intended for device sterilization.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873custserv@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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
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
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26
00677964153648Endo Carry-on Procedure Kit401124340112432026-05-26

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