AccessGUDID - DEVICE: TeslaDUO Remote Control (04255629200515)

GUDID

Device Identifier (DI) Information

Brand Name: TeslaDUO Remote Control
Version or Model: 5100047
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5100047
Company Name: MIPM Mammendorfer Institut für Physik und Medizin GmbH

Primary DI Number: 04255629200515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324416379 *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):	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?
62164	Patient monitor remote control	A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of a patient monitor from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the patient or healthcare provider.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153739	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: d5477358-344d-42a1-b346-3ca603f2bd5c
Public Version Date: February 02, 2024
Public Version Number: 1
DI Record Publish Date: January 25, 2024