FDA.reportPublic FDA data

100NX DUO Upgrade Kit with VELOCITY

Primary DI
10705037068173
Brand
100NX DUO Upgrade Kit with VELOCITY
Company
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Model
10137V
Catalog number
10137V
Device description
100NX DUO Upgrade Kit with VELOCITY
Published
2021-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, sterilization
MLRSterilizer, chemical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2
MLRSterilizer, ChemicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013003000
K111377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013003000APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDERAdvanced Sterilization Products2002-08-28FRG
K111377000STERRAD(R) 100NX STERILIZER DUO CYCLEAdvanced Sterilization Products2012-09-13MLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705037068173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503706817310705037068173

GMDN Terms#

Term, Definition table
TermDefinition
Plasma sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using vapours (or gases) in plasma state; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and then packed; a means to introduce the vapour [e.g., hydrogen peroxide (H2O2)] into the chamber; electrodes that are activated to convert the vapour into plasma; a radio-frequency generator; and cycle controls. The device is available in stand-alone (bulk) and tabletop units.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
Special Storage Condition, Specify00Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
Storage Environment Temperature15 Degrees Celsius30 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
Kit
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705037071319ULTRA GI™43381433812025-12-15
10705037042999STERRAD™99204992042026-06-03
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

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