AccessGUDID - DEVICE: Defibrillator Analyzer (B3356500)

GUDID

Device Identifier (DI) Information

Brand Name: Defibrillator Analyzer
Version or Model: Delta 3000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 650
Company Name: NETECH CORPORATION

Primary DI Number: B3356500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177242153 *Terms of Use

Device Description: Delta 3000 is a full function defibrillator analyzer including Transcutaneous Pacemakers. In addition to the capability of testing all bi-polar defibrillators, it tests all Transcutaneous pacers, Atrial and Ventricular pacemakers. Delta 3000 is compact, light weight and easy to use. Among the functions include energy, peak voltage as well as cardio version, 10 lead ECG Arrhythmia waveform. Test results can be easily uploaded to a PC through the serial port.

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?
36791	External defibrillator tester	An electronic instrument used to test an external defibrillator to ensure compliance with performance specifications. The device connects to the output of the defibrillator, typically via contact plates, and measures the energy delivered by the defibrillator into a standard resistive load; it may also perform transcutaneous pacemaker testing, provide waveform information, and execute other quality control procedures. The device may be used to test the function of an external defibrillator periodically, after repair, or for training purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRL	Tester, Defibrillator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961595	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: ee096cc1-dbbc-4436-aedf-16a545e7aefb
Public Version Date: July 20, 2018
Public Version Number: 4
DI Record Publish Date: June 16, 2017