AccessGUDID - DEVICE: Scope Buddy Plus Blanking Cap (00677964093067)

GUDID

Device Identifier (DI) Information

Brand Name: Scope Buddy Plus Blanking Cap
Version or Model: SB110HU1017
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SB110HU1017
Company Name: MEDIVATORS INC.

Primary DI Number: 00677964093067
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: Scope Buddy Plus Air Water Blanking Cap for Olympus Endoscopes

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):	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?
60417	Luer/non-ISO80369-standardized linear connector, reusable	A small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing or an external puncturing component. 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 [?]
K213833	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 93024ec8-649d-40aa-af57-f4ad28d0c394
Public Version Date: December 28, 2022
Public Version Number: 1
DI Record Publish Date: December 20, 2022