AccessGUDID - DEVICE: Air/water valve (04953170071249)

GUDID

Device Identifier (DI) Information

Brand Name: Air/water valve
Version or Model: MH-438
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GV404200
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170071249
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: "MH-438 A/W VLVE F/140 EVIS-140"

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):	Yes
Over the Counter (OTC):	No
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?
61792	Endoscopic procedure air/water valve, reusable	A non-sterile device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] and/or water whilst preventing backflow. It is in the form of an attachable valve with one or more settings such as closed, insufflation (allowing air/gas in), and irrigation/rinse (allowing water in). This is a reusable device intended to be reprocessed prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FET	Endoscopic video imaging system/component, gastroenterology-urology
FDF	Colonoscope And Accessories, Flexible/Rigid
FDS	Gastroscope And Accessories, Flexible/Rigid
FDT	Duodenoscope And Accessories, Flexible/Rigid
NWB	Endoscope, Accessories, Narrow Band Spectrum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
High-level Disinfectant
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b92bc45e-e611-428d-9e6d-52bca93ed215
Public Version Date: December 21, 2023
Public Version Number: 8
DI Record Publish Date: September 21, 2016