AccessGUDID - DEVICE: 100NX EXPRESS Upgrade Kit with VELOCITY (10705037068166)

GUDID

Device Identifier (DI) Information

Brand Name: 100NX EXPRESS Upgrade Kit with VELOCITY
Version or Model: 10134V
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10134V
Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Primary DI Number: 10705037068166
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 947451626 *Terms of Use

Device Description: 100NX EXPRESS Upgrade Kit with VELOCITY

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLR	Sterilizer, chemical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092622	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65c581a6-1900-4b9a-b31e-4615aca85abc
Public Version Date: June 22, 2023
Public Version Number: 2
DI Record Publish Date: July 19, 2021