FDA.reportPublic FDA data

EVOTECH™

Primary DI
10705037031016
Brand
EVOTECH™
Company
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Model
50014
Catalog number
50014
Device description
EVOTECH Equipment Kit
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEBAccessories, cleaning, for endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEBAccessories, Cleaning, For EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082392000
K140977000
K152189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082392000EVOTECH ENDOSCOPE CLEANER AND REPROCESSORAdvanced Sterilization Products2008-11-13FEB
K140977000EVOTECH ECRAdvanced Sterilization Products2014-12-22FEB
K152189000EVOTECH ECRAdvanced Sterilization Products (Asp)2016-07-20FEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705037031016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503703101610705037031016

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-29 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)783-7723complaints@aspus.jnj.com
+1(888)783-7723ASP-Complaints@asp.com

Regulatory Flags#

DUNS number
947451626
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705037043002STERRAD™99205992052018-05-31
10705037043019STERRAD™99206992062018-05-31
10705037043026STERRAD™99207992072018-05-31
10705037043033STERRAD™99208992082018-05-31
10705037043040STERRAD™99209992092018-05-31
10705037043057STERRAD™99210992102018-05-31
10705037043064STERRAD™99211992112018-05-31
20705037045553CIDEX™20392203922016-09-24
20705037045560CIDEX™20393203932016-09-24
10705037067244SEALSURE™14202NL14202NL2021-02-11
10705037048908STERRAD VELOCITY™43210432102017-10-10
10705037049400STERRAD VELOCITY™43210-3043210-302017-10-10
10705037048915STERRAD™43220432202017-10-10
10705037047628STERRAD™99239992392016-09-24
10705037047635APTIMAX™99240992402016-09-24
10705037047611APTIMAX™13839138392016-09-24
10705037015979Tyvek®12560125602025-12-18
20705037015976Tyvek®12560125602025-12-18
10705037015924Tyvek®12544125442025-12-17
10705037015948Tyvek®12557125572025-12-17

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04260306710577SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
04260306710584SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
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