AccessGUDID - DEVICE: ZeroWire (00818089022758)

GUDID

Device Identifier (DI) Information

Brand Name: ZeroWire
Version or Model: 90T2108
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Nds Surgical Imaging LLC

Primary DI Number: 00818089022758
Issuing Agency: GS1
Commercial Distribution End Date: January 13, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 081712583 *Terms of Use

Device Description: MEDTRONIC ACCESSORY KIT FOR 27" NON-NDS MONITORS, WIRELESS G2 TX/RX

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:	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?
32547	Medical networking interface unit	An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No Device Sizes

Device Record Status

Public Device Record Key: 633d0c4b-8cb2-4191-b340-19c804c291e8
Public Version Date: January 08, 2025
Public Version Number: 4
DI Record Publish Date: September 27, 2021