AccessGUDID - DEVICE: Evotech (10705037013654)

GUDID

Device Identifier (DI) Information

Brand Name: Evotech
Version or Model: 945701
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 945701
Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Primary DI Number: 10705037013654
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 947451626 *Terms of Use

Device Description: Adapter WTRJT-IRR Tube

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
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?
64640	Endoscope channel-opening adaptor	A small device intended to be manually attached to an endoscope channel/port (e.g., air/water channel, venting port), or an endoscope channel-opening button, to keep the channel open during sterilization/disinfection, typically to allow the luminal flow of a gas/solution or for pressure equalization between the endoscope interior and exterior (sterilizer chamber) to prevent damage. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEB	ACCESSORIES, CLEANING, FOR ENDOSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082392	000
K140977	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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e80d08f5-b3f6-4b10-bc4c-d5bc69e20a05
Public Version Date: August 16, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016