100NX DUO Upgrade Kit with VELOCITY

Basic Information

• Brand Name: 100NX DUO Upgrade Kit with VELOCITY
• Primary DI: 10705037068173
• Version / Model: 10137V
• Catalog Number: 10137V
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.
• Labeler DUNS: 947451626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-19
• Public Version: 3
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: fad8a3c2-cf36-463a-90b0-84cd55c98360

Device Description

100NX DUO Upgrade Kit with VELOCITY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MLR	Sterilizer, chemical	General Hospital	880.6860	2
FRG	Wrap, sterilization	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36305	Plasma sterilizer	A 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.	No	Active
12143	Instrument tray, reusable	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10705037068173	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K013003	000
K111377	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Type: Special Storage Condition, Specify
• Special Conditions: Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.