AccessGUDID - DEVICE: Medivators Hookup (00677964037726)

GUDID

Device Identifier (DI) Information

Brand Name: Medivators Hookup
Version or Model: Hookup
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 28523CAS
Company Name: MEDIVATORS INC.

Primary DI Number: 00677964037726
Issuing Agency: GS1
Commercial Distribution End Date: April 22, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: FUJI Hookup connects MEDIVATORS reprocessing equipment to endoscopes or related accessories.

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?
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
FEB	Accessories, cleaning, for endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102996	000
K172677	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: 2f319c95-50e4-4b38-a7b2-1618893a713c
Public Version Date: April 26, 2024
Public Version Number: 2
DI Record Publish Date: April 10, 2023