AccessGUDID - DEVICE: REMOTE ASSISTANT™ (00681490199285)

GUDID

Device Identifier (DI) Information

Brand Name: REMOTE ASSISTANT™
Version or Model: 9462
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00681490199285
Issuing Agency: GS1
Commercial Distribution End Date: October 10, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: SFTWR 9462 ACTVTR PATIENT REMOTE ASST

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?
31704	Cardiac pulse generator test magnet	A magnetized device used to test an inhibited or triggered type of pacemaker or defibrillator, and cause an inhibited or triggered generator to revert to asynchronous operation. The device is placed on the outside of the patient's thorax over the pacemaker/defibrillator for analysis of the implanted device's function. The magnet will activate the magnet sensitive relay in the pacemaker/defibrillator and will change the function of the implanted device. It is possible to evaluate the function of the implanted device via an electrocardiograph.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXY	implantable pacemaker Pulse-generator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970012	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: f1b6c693-9416-4005-abbb-bdce74ecb498
Public Version Date: October 12, 2018
Public Version Number: 4
DI Record Publish Date: September 23, 2014