AccessGUDID - DEVICE: BC Biomedical Defibrillator Analyzer Variable Load (00863313000323)

GUDID

Device Identifier (DI) Information

Brand Name: BC Biomedical Defibrillator Analyzer Variable Load
Version or Model: DA-2006-VL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DA-2006-VL
Company Name: BC GROUP INTERNATIONAL, INC.

Primary DI Number: 00863313000323
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 602930208 *Terms of Use

Device Description: Defibrillator Analyzer Variable Load, for use with DA-2006 and DA-2006P models.

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 [?]
K153210	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: e5a854db-0678-479c-8ab7-dd3c9eb8f770
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016