AccessGUDID - DEVICE: External Pacemaker Ananlyzer (B3359500)

GUDID

Device Identifier (DI) Information

Brand Name: External Pacemaker Ananlyzer
Version or Model: EXPMT 2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 950
Company Name: NETECH CORPORATION

Primary DI Number: B3359500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177242153 *Terms of Use

Device Description: The EXPMT 2000 will test and verify all the functions of any External Pacemaker including, transcutaneous and Atrial and Ventricular sequential pacemakers. Operation of the analyzer is menu driven via eight tactile keys and a large four line LCD display. Test measurements are simultaneously presented on the display. Five ECG snaps are standard along with an RS-232 serial port that allows for printing both a heading and test measurements on a separate printer. Information may also be sent to an external device. The external test load has twelve user-selectable loads from 100 to 1000 Ohms for use with transcutaneous pacemakers.

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):	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?
31700	External pacemaker analyser	An electronic instrument designed to test an external pacemaker to ensure compliance with performance specifications. The device connects to the output of the pacemaker to test any or all of the pulse generator's parameters including pulse duration, pulse amplitude, pulse rate, and sensing threshold. The device may be used to test the function of an external pacemaker periodically, after repair, or for training purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTC	Analyzer, Pacemaker Generator Function

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961582	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: 7132e39e-e704-4618-bee4-99f5f522293b
Public Version Date: July 20, 2018
Public Version Number: 4
DI Record Publish Date: June 16, 2017