AccessGUDID - DEVICE: SCOPE BUDDY PLUS TUBING (00677964082993)

GUDID

Device Identifier (DI) Information

Brand Name: SCOPE BUDDY PLUS TUBING
Version or Model: SB-110-HU1015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SB110HU1015
Company Name: MEDIVATORS INC.

Primary DI Number: 00677964082993
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: Scope Buddy Pump, 24 Hour Pump Tube

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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 [?]
K162128	000
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: c3e17010-9782-43b2-977f-e4d08f3cf0d8
Public Version Date: November 01, 2023
Public Version Number: 9
DI Record Publish Date: June 04, 2019