AccessGUDID - DEVICE: AUXILIARY WATER INLET CAP (04953170071713)

GUDID

Device Identifier (DI) Information

Brand Name: AUXILIARY WATER INLET CAP
Version or Model: MAJ-215
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GV732300
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170071713
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: MAJ-215 AUX WATER INLET CAP F/ GIF-1T140

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?
61723	Luminal device flushing tubing set, reusable	A collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDS	Gastroscope and accessories, flexible/rigid
FDF	Colonoscope and accessories, flexible/rigid
NWB	Endoscope, accessories, narrow band spectrum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131780	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant

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: 4a519b4e-e71f-4f38-8c11-065ce637a594
Public Version Date: April 22, 2024
Public Version Number: 11
DI Record Publish Date: September 21, 2016