AccessGUDID - DEVICE: Endoscopy trolley (04056634002237)

GUDID

Device Identifier (DI) Information

Brand Name: Endoscopy trolley
Version or Model: JEST1390N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: JEST1390N
Company Name: Joimax GmbH

Primary DI Number: 04056634002237
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 small

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?
32245	Medical monitor/light mount	A permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.	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: Separate trolley for joimax® Intracs em

Device Record Status

Public Device Record Key: bbc2b437-46c9-4409-a618-7535db608a7d
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: January 16, 2023