AccessGUDID - DEVICE: Datrend (B418PHASE380004400)

GUDID

Device Identifier (DI) Information

Brand Name: Datrend
Version or Model: Phase3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8000-440
Company Name: Datrend Systems Inc

Primary DI Number: B418PHASE380004400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 249968140 *Terms of Use

Device Description: Phase3 is the first Defibrillator / Pacer Analyzer specifically designed to test Pulsed Multiphasic defibrillators. – tests Monophasic, Biphasic and Pulsed Multiphasic Defibrillators, AEDs and Transcutaneous Pacers – see www.datrend.com for complete information

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 [?]
K062099	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: 976bd78c-bb0f-4295-b195-20205f049bb7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 18, 2017