AccessGUDID - DEVICE: andorate® Disposable Endoscope Valves Set (04897106952199)

GUDID

Device Identifier (DI) Information

Brand Name: andorate® Disposable Endoscope Valves Set
Version or Model: GAR065
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GA Health Company Limited

Primary DI Number: 04897106952199
Issuing Agency: GS1
Commercial Distribution End Date: May 08, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 686908512 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
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?
60760	Endoscope channel support kit	A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCX	Endoscopic Irrigation/Suction System
ODC	Endoscope Channel Accessory

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 06736e54-ab2b-4a84-863f-c5a14f21a0f0
Public Version Date: August 08, 2024
Public Version Number: 3
DI Record Publish Date: August 10, 2020