AccessGUDID - DEVICE: Biopsy Valve (04953170355943)

GUDID

Device Identifier (DI) Information

Brand Name: Biopsy Valve
Version or Model: MAJ-853
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170355943
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: "MAJ-853 Biopsy valves 140-AL5/160-OL5"

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

[?]

Product Code	Product Code Name
FDS	Gastroscope and accessories, flexible/rigid
ITX	Transducer, ultrasonic, diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021886	000

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

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: e3daa2b2-4397-408d-871a-7703e4afc295
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 21, 2016