AccessGUDID - DEVICE: PT Vicinity IT Workstation (04048675053682)

GUDID

Device Identifier (DI) Information

Brand Name: PT Vicinity IT Workstation
Version or Model: MS17277
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drägerwerk AG & Co. KGaA

Primary DI Number: 04048675053682
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 315578914 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
38452	Desktop computer	A non-dedicated, electrically-powered computer designed to be stationary on a desk or other work platform. It typically includes a microprocessor [central processing unit (CPU)], a monitor, and a keyboard/mouse. When used with dedicated software the computer may function as a medical device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSX	System,Network And Communication,Physiological Monitors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060254	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: af8f7a05-5b8d-4d24-a9c9-0e791ae9c182
Public Version Date: July 25, 2023
Public Version Number: 5
DI Record Publish Date: October 24, 2015