AccessGUDID - DEVICE: Endoscopy trolley (04056634003517)

GUDID

Device Identifier (DI) Information

Brand Name: Endoscopy trolley
Version or Model: JEST2020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: JEST2020
Company Name: Joimax GmbH

Primary DI Number: 04056634003517
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 344267187 *Terms of Use

Device Description: joimax® Endoscopic Trolley 4th Gen.

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?
35124	Medical device integration rack	A device that is designed as an instrument rack (maybe cabinet-like with closed sides) and is used for mounting and organizing several medical devices that are intended to interact (integrated instrumentation). It is typically mobile (on wheels) and has built-in grounded outlets, pull-out shelves, working surfaces, and may even be equipped with a built-in transformer. This device, when supplied with the instrumentation fitted, will become a system and will require product identification of the whole as a system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZN	CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Device Size Text, specify: up to 6 devices and 3 monitors, drawer, infusion s

Device Record Status

Public Device Record Key: e63d0c57-b57b-4dcc-af7c-b7f05e28aac9
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: January 16, 2023